FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA
TABLE OF CONTENTS
STUDY CATEGORY...... PAGE CLINICAL TRIAL...... 2 BEHAVIORAL/EPIDEMIOLOGIC...... 43 BASIC SCIENCE/VIROLOGY...... 71 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 2 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Clinical Trials
MEDICATION TRIALS: ViiV HealthCare/Pfizer - PI: Steven Santiago, M.D Recruitment Begins MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE A4001095:Community A multicenter, AIDS Resource, Inc. (Care Resource)9/15/2011 – 5 studies No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY randomized, double-blind,3510 BiscayneContacts for Boulevard, further Suite 300 THERAPY comparative trial of information: Maraviroc+Darunavir /Ritonavir LeandroMiami, Pisani FL 33137 ELIGIBILITY : versus Emtricitabine/Tenofovir 305/576-1234 ext 276 Men and women ≥ 18 yrs of age who have + Darunavir /Ritonavir for the [email protected] never taken antiretroviral drugs and have a treatment of antiretroviral- or viral load > 1000 copies/ml and naïve HIV infected patients with Milagros Rodriguez CD4 > 100 cells/mm3 CCR5 Tropic HIV-1 305/576-1234 ext 244 mrodriguez@careresource NCT01345630(?) .org MEDICATION TRIALS: Tobira Therapeutics -652-2-202: PI: Steven Santiago, M.D Recruitment Begins MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE A phase 2b, 8/20/2011 No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY multicenter, double blind Contacts for further THERAPY comparative study to evaluate information: the efficacy, safety and Leandro Pisani Eligibility: tolerability of Cenicriviroc in 305/576-1234 ext 276 Men and women > HIV‐1 infected, antiretroviral [email protected] 18 years of age with CCR5-tropic virus by treatment‐naïve patients with or GT and Trofile-ES who have never taken only CCR5‐tropic virus. Milagros Rodriguez antiretroviral drugs; viral load > 5,000 Participants will receive either 305/576-1234 ext 244 copies/ml and CD4 > 250 cells/mm3 once‐daily 100 mg or 200 mg mrodriguez@careresource doses of Cenicriviroc in .org combination with Truvada or once‐daily Sustiva plus Truvada. MEDICATION TRIALS: Viiv HealthCare/ Pfizer - PI: Luis Saenz D.O Enrollment Open MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE A4001098: A multi-center, No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY randomized, blinded, placebo- Contacts for further THERAPY controlled study to evaluate the information: safety of Maraviroc in Leandro Pisani Eligibility: Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 3 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
combination with other 305/576-1234 ext 276 ≥ 18 yrs of age co-infected with Hepatitis C antiretroviral agents in HIV-1- [email protected] or B and not receiving treatment. for infected subjects co-infected or Hepatitis B or C. Undectectable viral load with Hepatitis C and/or Milagros Rodriguez for at least 3 months. No prior treatment Hepatitis B virus. 305/576-1234 ext 244 with Maraviroc or another CCR5 mrodriguez@careresource .org
EPZ113734 - A Prospective, PI: Steven Santiago, M.D. MEDICATION TRIALS: Treatment Naïve – MEDICATION TRIALS: Randomized, Multicenter, Luis Saenz D.O. No PAST USE OF ANTIRETROVIRAL Treatment Naïve – No PAST USE Open-Label Study to Compare THERAPY OF ANTIRETROVIRAL THERAPY the Efficacy and Safety of Simplifying from a Regimen of Contacts for further Atazanavir + Ritonavir + information: Tenofovir/Emtricitabine to Milagros Rodriguez Atazanavir + 305/576-1234 ext 244 Abacavir/Lamivudine Without mrodriguez@careresource Ritonavir for 48 .org
MEDICATION TRIALS: GlaxoSmithKline -EPZ113734: PI: Steven Santiago, M.D. Enrollment Open MEDICATION TRIALS: Treatment Treatment experienced (history A prospective, randomized, experienced (history of Current or Past of Current or Past Use of multicenter, open-label study to Contacts for further Use of Antiretroviral Therapy) Antiretroviral Therapy) compare the efficacy and safety information: of simplifying from a regimen of Leandro Pisani Eligibility: Atazanavir + 305/576-1234 ext 276 18 yrs of age who have been undetectable Ritonavir/Tenofovir/ [email protected] for more than 3 months and receiving a Emtricitabine to Atazanavir + or regimen of ATV/RTV (300mg/100 mg) Abacavir/ Lamivudine without Milagros Rodriguez +TDF/FTC (300mg/200 mg) as initial or first Ritonovir for 48 weeks in 305/576-1234 ext 244 and only switch regimen for at least 6 virologically suppressed, HIV- mrodriguez@careresource months. infected HLA-B 5701 negative .org subjects
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA UNIVERSITY OF CENTRAL FLORIDA – 1 study Presenter: Alexander M. Cole, Ph.D.
CLINICAL TRIAL Contract with HIV Vaccine Trials Alexander M. Cole, Ph.D. Microbiology and cGLP laboratory processing for clinical trial Network (HVTN) and Fred (PI of lab contract); Edwin Molecular Biology Hutchinson Cancer Research DeJesus, M.D. (PI of Center to process specimens for clinical contract) study# HVTN505 NOVA SOUTHEASTERN UNIVERSITY – 6 studies Presenter: Isa Fernandez, Ph.D.
CLINICAL TRIAL Young Hispanic Men – Entre Maria Isabel Fernandez, College of Osteopathic HIV prevention among young Culturas: Navigating Culture, Ph.D. G. Stephen Bowen, Medicine Hispanic/Latino MSM Identity and HIV Risk M.D. CLINICAL TRIAL Project POWER: A Health Maria Isabel Fernandez, College of Osteopathic HIV prevention among black men who Promotion and HIV Risk Ph.D Medicine have sex with men and women Reduction Intervention for Black Men. CLINICAL TRIAL Adolescent Trials Network for Maria Isabel Fernandez, College of Osteopathic HIV and adolescents (both infected and at HIV interventions Ph.D. G. Medicine risk for HIV) CLINICAL TRIAL Risk Reduction for Urban Steven P. Kurtz, Ron Stall, Division of Applied HIV, MSM, drug use National Institute on Substance Using MSM Hilary L. Surratt Interdisciplinary Studies Drug Abuse Grant # DA024579 CLINICAL TRIAL A Self-Assessment Intervention Steven P. Kurtz, Hilary L. Division of Applied HIV, young adults, drug use National for Young Adult Polydrug Users Surratt Interdisciplinary Studies Institute on Drug Abuse Grant # DA019048 at Risk for HIV CLINICAL TRIAL Case Management Alternatives Hilary L. Surratt, Gladys Division of Applied HIV, women, drug use National Institute on for African American Women at Ibanez Interdisciplinary Studies Drug Abuse Grant # DA013131 High Risk for HIV
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
University of Miami Department of Medicine, Division of Infectious Diseases – 7 studies Jackson Medical Towers, 8th Floor East 1500 NW 12th Avenue Miami, FL 33136
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
MEDICATION TRIALS: ViiV HealthCare/Pfizer - P.I.: Dushyantha Waiting for IRB approval MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE A4001095–1019: A multicenter, Jayaweera, M.D. No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY randomized, double-blind trial THERAPY comparing Maraviroc + Contact for further Darunavir/ Ritonavir vs. information: Eligibility: Emtricitabine/Tenofovir + Tom Tanner, R.N. Men and women > Darunavir/Ritonavir for the 305/243-5621 18 years of age with CCR5-tropic HIV-1 treatment of antiretroviral [email protected] who have never taken antiretroviral drugs naïve HIV-infected patients with and have a viral load > 1,000 copies/ml CCR5-tropic HIV-1 and CD4 > 100 cells/mm3
MEDICATION TRIALS: Tobira Therapeutics -652: A P.I.: Dushyantha Begins 9/1/2011 MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE phase IIb, Jayaweera, M.D. No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY multicenter, double blind THERAPY comparative study to evaluate the efficacy, safety and Contact for further Eligibility: tolerability of Cenicriviroc in information: Men and women > HIV‐1 infected, antiretroviral Tom Tanner, R.N. 18 years of age with CCR5 tropic virus who treatment naïve patients with 305/243-5621 have never taken antiretroviral drugs; BMI only CCR5‐tropic virus. [email protected] < 35 kg/m2, Participants will receive either viral load > 5,000 copies/ml and CD4 > 250 once‐daily 100 mg or 200 mg cells/mm3 doses of Cenicriviroc in combination with Truvada or once‐daily Sustiva plus Truvada MEDICATION TRIALS: University of P.I.: Michael Kolber, M.D. Begins 9/15/2011 MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE Minnesota/Insight: Strategic No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY Timing of Anti-Retroviral Contact for further THERAPY Treatment (START): A information: multicenter study of the Tom Tanner, R.N. Eligibility: International Network for 305/243-5621 Healthy HIV infected men and women > 18 Strategic Initiatives in Global [email protected] years of age who have never taken HIV Trials (INSIGHT) antiretroviral drugs or interleukin-2 and have CD4 > 500 cells/mm3 MEDICATION TRIALS: Merck and Co. 35835: A P.I.: Rafael Campo, M.D. Enrollment open MEDICATION TRIALS: Treatment
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Treatment experienced (history prospective, open-label, single- experienced (history of Current or Past of Current or Past Use of center pilot study to evaluate Contact for further Use of Antiretroviral Therapy) Antiretroviral Therapy) the addition of Raltegravir to information: established suppressive Tom Tanner, R.N. Eligibility: antiretroviral therapy while 305/243-5621 Men and women > 18 years of age with monitoring changes in markers [email protected] HIV-1. CD4 count < 350 cells/mm3 at time of immune activation among of enrollment HIV-1 infected individuals without adequate immune restoration. MEDICATION TRIALS: Viiv HealthCare/Pfizer - P.I.: Dushyantha Begins 9/15/2011 MEDICATION TRIALS: Treatment Treatment experienced (history A4001098–1021: A Jayaweera, M.D. experienced (history of Current or Past of Current or Past Use of multicenter, randomized, Use of Antiretroviral Therapy) Antiretroviral Therapy) blinded, placebo-controlled Contact for further study to evaluate the safety of information: Eligibility: Maraviroc in combination with Tom Tanner, R.N. Men and women > 18 years of age who are other antretroviral agents in 305/243-5621 available for 148 weeks. Undetectable HIV-1 infected subjects co- [email protected] viral load, detectable HCV RNA and/or infected with Hepatitis C and/or Hepatitis B positive. Treatment with Hepatitis B virus. antiretroviral therapy excluding Ritonavir. MEDICATION TRIALS: University of Miami P.I.s: Luis Espinoza, Enrollment Open MEDICATION TRIALS: Treatment Treatment experienced (history Developmental Center for AIDS M.D./Michael Kolber, experienced (history of Current or Past of Current or Past Use of Research: Recovery of latent M.D. Use of Antiretroviral Therapy) Antiretroviral Therapy) reservoirs after treatment for lymphoma in HIV infected Contact for further Eligibility: patients (Pilot Study). information: Men and women > 18 years of age. HIV+ Tom Tanner, R.N. lymphoma. On highly active antiretroviral 305/243-5621 therapy. Non- detectable viral load <50. [email protected]
MEDICATION TRIALS: Vitamin Study – Double-Blind, P.I.: Dushyantha Waiting UM IRB approval MEDICATION TRIALS: Treatment Treatment experienced (history randomized, placebo controlled Jayaweera, MD experienced (history of Current or Past of Current or Past Use of study of Livethesource® daily Use of Antiretroviral Therapy) Antiretroviral Therapy) multi-vitamin (MVI) compared Contact for further with standard MVI in patients information: Eligibility: infected with HIV-1 Tom Tanner, R.N. HIV-1 infected men and women > 18 yrs of Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 11 of 48
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305/243-5621 age. On stable highly active antiretroviral [email protected] therapy. CD4 <500 cells/mm3
University of Miami Department of Pediatrics, Division of Infectious Diseases and Immunology – 1 study Batchelor Children’s Institute, 1580 NW 10 Avenue Suite 287 Miami, Fl 33136
CLINICAL TRIAL International Maternal P.I.: Gwendolyn Scott, Enrollment open MEDICATION TRIALS: Pediatric Adolescent AIDS M.D. Clinical Trials (IMPAACT) – Eligibility: PROMISE Study: The study will Contact for further Pregnant women who have only taken determine if women who information: antiretroviral therapy in pregnancy and receive highly active Patricia Bryan, R.N. have CD4 cells of 400 or higher. antiretroviral therapy (HAART) 305/243-4447 during pregnancy and continue [email protected] their regimen after delivery will have less morbidity and mortality than those who only receive HAART during pregnancy and stop after delivery. The study also will evaluate the likelihood of developing resistance to HIV meds in women who stop compared with those who continue HAART after delivery. The study will supply antiretroviral medications.
University of Miami AIDS HIV Women’s Program – 2 studies (Dept. Obstetrics and Gynecology) Clinical Research Building 1120 NW 14th Street, 7th Floor Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 12 of 48
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Miami, FL 33136 MEDICATION TRIALS: Tibotec. A single arm open P.I.: Salih Yasin, M.D. Enrollment open MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE label study to assess the No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY pharmacokinetics of Rilpivirine Contact for further THERAPY in HIV-1 pregnant women. information: Yvette Rivero Eligibility: 305/243-2169 Women ≥ 18 years of age who have never [email protected] taken antiretroviral drugs and are between 18-24 weeks pregnant.
MEDICATION TRIALS: Tibotec. A single arm open P.I.: Salih Yasin, M.D. Enrollment open MEDICATION TRIALS: Treatment Treatment experienced (history label study to assess the experienced (history of Current or Past of Current or Past Use of pharmacokinetics of Contact for further Use of Antiretroviral Therapy) Antiretroviral Therapy) Darunavir/Ritonavir and/or information: Etravirine in HIV-1 pregnant Yvette Rivero Eligibility: women 305/243-2169 Women ≥ 18 years of age, with a history of [email protected] taking antiretroviral drugs, who are between 18-24 weeks pregnant. Wohlfeiler, Piperato & Associates, LLC – 6 studies 1613 Alton Road Miami Beach, FL 33139 MEDICATION TRIALS: Treatment Sangamo Biosciences P.I.: Michael Wohlfeiler, Selected as a site – MEDICATION TRIALS: Treatment Naïve – Naïve – No PAST USE OF M.D. waiting for contract No PAST USE OF ANTIRETROVIRAL ANTIRETROVIRAL THERAPY (selected as site – details approval THERAPY pending) Contact for further information: Eligibility: Daniel Guzman, CRC Men and women > 305/538-1400 ext: 222 18 years of age never taken antiretroviral [email protected] drugs and have a viral load > 2,500 m copies/ml and CD4 > 500 cells/mm3
MEDICATION TRIALS: Sangamo Biosciences P.I.: Michael Wohlfeiler, Selected as a site – MEDICATION TRIALS: Treatment Naïve – Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 13 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Treatment Naïve – No PAST USE M.D. waiting for contract No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY (selected as site – details approval THERAPY pending) Contact for further information: Eligibility: Daniel Guzman, CRC Men and women > 305/538-1400 ext: 222 18 years of age never taken antiretroviral [email protected] drugs and have a viral load > 2,500 m copies/ml and CD4 > 500 cells/mm3
MEDICATION TRIALS: Gilead Sciences – GS-0118: A P.I.: Michael Wohlfeiler, Enrollment Open MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE phase III trial to characterize the M.D. No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY effect of Cobicistat-based THERAPY regimens in patients with mild Contact for further to moderate renal impairment. information: Eligibility: NCT01363011 Daniel Guzman, CRC HIV infected men and women > 18 years of 305/538-1400 ext: 222 age who have never taken antiretroviral [email protected] drugs, have a viral load > 1,000 copies, and m have mild to moderate renal impairment.
Contact: Andrew Plummer (650) 522-6173 [email protected] m
MEDICATION TRIALS: ViiV Healthcare –111762: A P.I.: Michael Wohlfeiler, Enrollment Open MEDICATION TRIALS: Treatment Treatment experienced (history multicenter, randomized, M.D. experienced (history of Current or Past of Current or Past Use of double-blind study of the safety Use of Antiretroviral Therapy) Antiretroviral Therapy) and efficacy of GSK 1349572 (50 Contact for further mg. once daily) versus information: Eligibility: Raltegravir (400 mg. twice Daniel Guzman, CRC HIV-infected men and women > daily) added to an optimized 305/538-1400 ext: 222 18 years of age who are antiretroviral background regimen. [email protected] experienced and are integrase inhibitor m naïve.
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
MEDICATION TRIALS: ViiV Healthcare – ASSURE: A P.I.: Michael Wohlfeiler, Enrollment Open MEDICATION TRIALS: Treatment Treatment experienced (history randomized phase 4 switch M.D. experienced (history of Current or Past of Current or Past Use of study designed to compare the Use of Antiretroviral Therapy) Antiretroviral Therapy) efficacy and safety of Contact for further simplifying therapy from a information: Eligibility: regimen of atazanavir (ATV) + Daniel Guzman, CRC Men and women > ritonavir (RTV) + 305/538-1400 ext: 222 18 years of age. 1) TDF/3TC + ATV/r tenofovir/emtricitabine [email protected] (300/100 mg) must be patient’s initial (TDF/FTC) to a regimen of ATV + m antiretroviral regimen or the first or abacavir sulfate/lamivudine second switch regimen, 2) virologically (ABC/3TC) without RTV in suppressed on TDF/FTC + ATV/r, 3) must virologically suppressed, HIV-1 be HLA-B*5701 negative. infected subjects. Salix Pharmaceuticals – P.I.: Michael Wohlfeiler, Enrollment open Trials for HIV-Associated Conditions Trials for HIV-Associated CFHD3092: This study is being M.D. Conditions conducted to evaluate the Eligibility: safety and tolerability of Contact for further HIV-infected adults who have been on crofelemer 125 mg twice a day, information: antiretroviral therapy for at least 4 weeks taken orally, over 48 weeks of Daniel Guzman, CRC prior to screening with self-reported therapy in human 305/538-1400 ext: 222 presence of diarrhea immunodeficiency virus-positive [email protected] (HIV+) subjects with diarrhea. m NCT01374490
Miami Beach Community Health Center, Inc. – 1 study 710 Alton Road Miami Beach, FL 33139 KOWA Research Institute – P.I.: Mark Keller, M.D. Enrollment open Trials for HIV-Associated Conditions Trials for HIV-Associated NK-104-4.05US: A study Conditions comparing Pitavastatin (4 Contact for further E ligibility: mg.) vs. Pravastatin (40 mg.) information: HIV-infected men and women, ages 18-70, in HIV-infected subjects with Alice Lopez who have taken antiretroviral drugs for at dyslipidemia. 305/866-8915 least 6 months. LDL > 130 mg. and < 220
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
mg. and triglyceride levels < 400. University of Miami, AIDS Clinical Research Unit – 4 studies Elliot Building, Room 2016 1800 NW 10th Avenue, Miami FL 33136 MEDICATION TRIALS: AIDS Clinical Trials Group – P.I.: Margaret Fischl, M.D. Expect to begin enrolling MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE 5303: A phase-IIIb trial to 9/2011 No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY evaluate bone, immunologic, Contacts for further THERAPY virologic and neuro-cognitive information: Eligibility: effects of Maraviroc-containing Juan Casuso Men and women > antiretroviral therapy regimen 305/243-3838 18 years of age with documented CCR5 in patients infected with CCR5 [email protected] only virus. Excludes those who are Hep- tropic HIV-1 B+, pregnant, weigh > 300 lbs., have bone fractures related to osteoporosis or bone fragility, or active drug or alcohol abuse. MEDICATION TRIALS: ViiV Healthcare/Pfizer UK-427: P.I.: Margaret Fischl, M.D. Enrollment Open MEDICATION TRIALS: Treatment Naïve – Treatment Naïve – No PAST USE A comparative study of No PAST USE OF ANTIRETROVIRAL OF ANTIRETROVIRAL THERAPY Maraviroc/ Darunavir/Ritonavir Contacts for further THERAPY vs. Truvada/Darunavir/ information: Eligibility: Juan Casuso Ritonavir in ARV-naïve Men and women > 18 years of age with 305/243-3838 individuals with CCR5 tropic CCR5 tropic HIV-1 infection. Excludes [email protected] HIV-1 infection pregnant women and those with acute hepatitis or pancreatitis, renal insufficiency, HepB+ or CXCR4 HIV-virus. AIDS Clinical Trials Group – A- P.I.: Margaret Fischl, M.D. Expected to begin Trials for HIV-Associated Conditions Trials for HIV-Associated 5279: A phase-III trial of short 9/2011 Eligibility: Conditions course Rifapentine/ Isoniazid for Contacts for further HIV-1 infection, positive TB test prior to the prevention of active information: study entry. Excludes those with current tuberculosis (TB) in HIV-infected Juan Casuso pregnancy, active TB within 2 years of individuals with latent TB 305/243-3838 study entry, on P.I.-based or Raltegravir – infection. [email protected] regimen; liver cirrhosis, acute hepatitis. AIDS Clinical Trials Group - P.I.: Margaret Fischl, M.D. Enrollment open Trials for HIV-Associated Conditions Trials for HIV-Associated A5247: A phase II clinical trial Eligibility:
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Conditions to evaluate the safety, Contacts for further Men and women ≥ 18 yrs of age with a tolerability and immune information: history of shingles (herpes zoster in the response of ZOSTAVAX® (Zoster Juan Casuso past one year) who are taking combination Vaccine Live) in HIV-1-infected 305/243-3838 ARV therapy and have a viral load < 50 adults on combination ART. [email protected] copies/ml and CD4 cell count ≥ 200
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FLORIDA INTERNATIONAL UNIVERSITY – 3 Studies Presenter: Mario De La Rosa, Ph.D. CLINICAL TRIAL Zinc Therapy in Zinc Deficient Marianna Baum, PI, and Robert Stempel College of A seven-year clinical trial that compared HIV+ Drug Users Adriana Campa, Co-PI Public Health and Social the effects of zinc /placebo Supplements to this project: Work (Recently supplementation on HIV disease Effect of Zinc Supplementation Completed Studies) progression, and extended its research on Cytokine Modulation, HIV- objectives by funded supplemental HCV Coinfection and Antioxidant research into the effects of zinc in Status modulating cytokine responses and decreasing oxidative stress in HIV/HCV co- infection Funded by NIDA CLINICAL TRIAL "HIV-Risk Reduction for Teens in Jonathan Tubman (PI) Robert Stempel College of Randomized, clinical trial to evaluate the Alcohol Treatment.” Public Health and Social efficacy of clinic-based HIV-risk reduction Work (Recently intervention for multi-ethnic youth Completed Studies) undergoing outpatient treatment for alcohol and other drug abuse problems; Funded by NIAAA CLINICAL TRIAL Micronutrient Therapy in HIV+ Marianna Baum (PI) and Robert Stempel College of A seven-year clinical trial of micronutrient Adults in Botswana. Adriana Campa, Co-PI Public Health and Social rplementation in collaboration with the Work (Recently Harvard School of Public Health and the Completed Studies) Botswana-Harvard Partnership. Funded by NIDA VACCINE & GENE THERAPY INSTITUTE – FLORIDA – 3 Studies Presenters: Rafick Pierre Sékaly, Ph.D. & Lydie Trautmann, Ph.D.
CLINICAL TRIAL A Pilot Study Evaluating the Dr Campo, Dr Stevenson, Microbiology and HIV reservoirs Addition of Raltegravir to Dr Dr. Pahwa, Dr. Immunology and Established Suppressive Chomont University of Miami Antiretroviral Therapy while (dcFAR) Monitoring Changes in Markers of Immune Activation among
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
HIV-1 Infected Individuals Without Adequate Immune Restoration CLINICAL TRIAL Recovery of latent reservoirs Dr. Espinoza, Dr. Kolber Microbiology and HIV reservoirs after treatment for lymphoma in and Dr. Ramos, Dr. Sekaly, Immunology and HIV infected patients: A Pilot Dr. Chomont University of Miami Study (dcFAR) CLINICAL TRIAL Evaluation of HAART initiation Dr. Ananworanich, Dr. VGTI and US Military HIV reservoirs during acute HIV infection on Kim, Dr. Chomont, Dr. HIV Research HIV reservoir persistence Sekaly Program
University of Florida Center for HIV/AIDS Research Education and Service (UF CARES) – 15 Studies Presented by Mobeen Rathore, M.D.
CLINICAL TRIAL Efficacy of an Accelerated, High- Levonne Mitchell-Samon, Infectious Diseases Hepatitis B Vaccination scheduling and dosing Dose, Hepatitis B Immunization MD (PI) Sub-Investigators: Division and in HIV-Infected Patients Series in HIV-Infected Patients Michael Sands, MD, MPH Department of &TM Nilmarie Guzman, Health Boulevard MD Christina L. Bailey, MD Comprehensive Care Center CLINICAL TRIAL Strategic Timing of Michael Sands, MD, MPH Infectious Diseases HIV and initiation of ART AntiRetroviral Treatment & TM Sub-Investigators: Division (START) Nilmarie Guzman, MD Christina L. Bailey, MD Mobeen Rathore, MD CLINICAL TRIAL A Phase I/II, Multicenter, Open- Mobeen Rathore, MD Pediatrics Keywords: HIV, Raltegravir in HIV-infected Label, Noncomparative Study of children, teens the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK- 0518) in HIV-1 Infected Children
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
and Adolescents IMPAACT P1066 CLINICAL TRIAL A Phase II Safety and Mobeen Rathore, MD Pediatrics HIV, HPV Vaccine Immunogenicity Study of Quadrivalent Human Papilloma Virus [TYPES 6, 11, 16, 18] L1 Virus-Like Particle [VLP] Vaccine (GARDASIL®) in HIV-Infected Children (greater or equal to) 7 to < 12 Years of Age P1047 Ver. 1.0 CLINICAL TRIAL A5240: A Phase II Study to Mobeen Rathore, MD Pediatrics HIV, HPV Vaccine Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females CLINICAL TRIAL A5257: A Phase III Comparative Mobeen Rathore, MD Pediatrics HIV infected women; HIV medication study Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers (The ARDENT Study: Atazanavir, Raltegravir, or Darunavir with Emtricitabine- Tenofovir for Naïve Treatment) CLINICAL TRIAL An Open-label, Multicenter, Mobeen Rathore, MD Pediatrics HIV, maraviroc Multiple-dose Pharmacokinetic & 48-week Safety & Efficacy Trial of Maraviroc in Combination with Optimized Background Therapy for the Treatment of Antiretroviral- experienced CCR5-tropic HIV-1 Infected Children 2-18 Years of Age (A4001031) Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 21 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
NCT00791700
CLINICAL TRIAL IMPAACT P1065: Phase I/II, Mobeen Rathore, MD Pediatrics HIV, meningococcal conjugate vaccine, Study of Safety and children, youth Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine (MCV-4) In HIV-Infected Children and Youth CLINICAL TRIAL IMPAACT P1086 A Phase II Study Mobeen Rathore, MD Pediatrics HIV-infected pregnant women, H1N1 influenza to Assess the Safety & vaccine Immunogenicity of an Inactivated A(H1N1) 2009 Monovalent Vaccine in HIV-1 Infected Pregnant Women CLINICAL TRIAL IMPAACT P1088: A Phase II Mobeen Rathore, MD Pediatrics HIV and H1N1 Study to Assess the Safety & Immunogenicity of an Inactivated Influenza A (H1N1) 2009 Monovalent Vaccine in HIV-1 Perinatally Infected Children & Youth CLINICAL TRIAL Phase III, Randomized Trial of Mobeen Rathore, MD Pediatrics the Safety & Efficacy of Three Neonatal Antiretroviral Regimens for the Prevention of Intrapartum HIV-1 Transmission (NICHD/HPTN 040/P1043) CLINICAL TRIAL A5257: A Phase III Comparative Mobeen Rathore, MD Pediatrics HIV infected women; HIV medication study Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers (The ARDENT Study: Atazanavir, Raltegravir, or Darunavir with Emtricitabine/Tenofovir for Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 22 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Naïve Treatment) CLINICAL TRIAL An International, Multicenter, Nilmarie Guzman, MD (PI) Infectious Diseases HIV-1; maraviroc safety in long-term use Prospective Observational Study Sub-Investigators: Michael Division of the Safety of Maraviroc used Sands, MD, MPH & TM, with Optimized Background Christina L. Bailey, MD, Therapy in Treatment- Levonne Mitchell-Samon, Experienced HIV-1 Infected MD Patients (POEM) Catherine Rogers, PA-C Ne’Tosha Dopson, PA-C CLINICAL TRIAL IMPACCT 1077 HS: HAART Mobeen Rathore, MD Pediatrics HIV, post partum Standard Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere), Version 1.0 CLINICAL TRIAL Pharmacotherapy for Hazardous Robert Cook, MD, MPH Pediatrics Hazardous Drinking Behavior, HIV, alcohol, Drinking in HIV Infected and Mobeen Rathore, MD naltrexone Women: Randomized Trial Contact: Robert L Cook, MD, MPH 352-273-5869 [email protected] Contact: Manju Karki, MPH 352-273-9562 [email protected]
BROWARD CHILDREN’S DIAGNOSTIC & TREATMENT CENTER - 12 Studies Presented by Ana Puga, M.D. CLINICAL TRIAL ATN 061: Preservation and Ana Puga, MD CFAP Research Antiretroviral Therapy (ART) in adolescents Expansion of T-cell Subsets Barbara Moscicki Following Highly Active Antiretroviral Therapy (HAART) De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 and HIV RNA < 100,000 Initiating HAART (on-going)
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
CLINICAL TRIAL ATN 064: Immunogenicity, Safety, Ana Puga, MD CFAP Research Human Papilloma Virus (HPV) vaccine in Tolerability, and Behavioral adolescents Consequences of an HPV-6,-11,- 16,-18 Vaccine in HIV-Infected Young Women (closed) CLINICAL TRIAL Campbell Study: HPV Infections Ana Puga, MD CFAP Research HPV in Perinatally Infected Children/Youth and Associated Morbidity in Children and Adolescents Perinatally Infected with HIV CLINICAL TRIAL IMPAACT 1077HS: HAART Ana Puga, MD CFAP Research HIV and Pregnancy Standard Version of the PROMISE Postpartum Antiretroviral Treatment Strategy Study (Promoting Maternal and Infant Survival Everywhere) (recruiting) CLINICAL TRIAL IMPAACT 1058A: Intensive Ana Puga, MD CFAP Research Pharmacokinetics of Newer Agents in Pharmacokinetic Studies of New Children/Youth. Classes of Antiretroviral Drug combinations in Children, Adolescents and Young Adults (recruiting) CLINICAL TRIAL IMPAACT 1066: A Phase I/II, Ana Puga, MD CFAP Research Raltegravir in Children Multicenter, Open-Label, Pharmacokinetics Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (MK-0518) in HIV-1 Infected Children and Adolescents (recruiting) CLINICAL TRIAL IMPAACT A5240: A Phase II Study Ana Puga, MD CFAP Research HPV in Adult HIV positive females to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 24 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
HIV-1 Infected Females (recruiting) CLINICAL TRIAL IMPAACT A5241: The Optimized Ana Puga, MD CFAP Research Salvage Antiretroviral Therapy (ART) Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1 Infected Treatment- Experience Subjects Using the cPss to Select an Effective Regimen (recruiting) CLINICAL TRIAL IMPAACT A5257: A Phase III Ana Puga, MD CFAP Research Antiretroviral Therapy Strategy Comparative Study of Three Non- Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1 Infected Volunteers (recruiting) CLINICAL TRIAL IMPAACT P1063: Phase I/II Safety Ana Puga, MD CFAP Research Pharmacokinetics and Efficacy Investigation of Cholesterol treatment for children/youth Atorvastatin for Treatment of Increased LDL Cholesterol In HIV- Infected Children, Adolescents, and Young Adults (recruiting) CLINICAL TRIAL IMPAACT P1093: A Phase I/II, Ana Puga, MD CFAP Research Novel Intergrase in children Multi-Center, Open-Label Pharmacokinetics Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, A Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents. 2/9/2011 - Present (recruiting) CLINICAL TRIAL IMPAACT P1096: A Companion Ana Puga, MD CFAP Research Human Parainfluenza Vaccine in HIV negative Protocol to CIR Protocol Number: Children CIR255 Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 25 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Phase 1 Study to Determine the Safety, Infectivity, Immunogenicity and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval (recruiting) ClinicalTrials.gov Website Studies – 39 Additional Studies CLINICAL TRIAL Sleep Quality and Presence of Sleep Supriya Mannepalli, MD, University of Florida Disordered Breathing In An Inner City Akram Khan, MD African American HIV Infected Population Aged 50 Years and Older Contact: Katherine Rogers, NCT00692965 BSN904-253-1261 [email protected]. us Contact: Supriya Mannepalli, MD904-253-1040 Supriya_ mannepalli @doh.stat e.fl.us
CLINICAL TRIAL A Phase 2B Multicenter, Randomized, Study Director: Pfizer CT.gov Percentage of subjects with HIV-1 RNA <50 copies/mL at 24 weeks.; The Comparative Trial Of UK-453,061 Call CeFnter percentage of subjects with HIV-1 RNA <50 copies/mL and <400 copies/mL at Versus Etravirine In Combination 1-800-718-1021 various time points; The change from baseline in log10 transformed HIV 1 With Darunavir/Ritonavir And A RNA levels; Assessment of Genotypic and phenotypic resistance at various Nucleos(t)Ide Reverse Transcriptase time points; The time-averaged difference (TAD) in log10 transformed HIV 1 Inhibitor For The Treatment Of RNA levels at various time points.; The percentage of subjects with virologic Antiretroviral Experienced HIV-1 response at different time points.; Change from baseline in CD4+ cell counts Infected Subjects With Evidence Of (absolute and percentage).; Safety and tolerability as measured by NNRTI Resistant HIV-1 spontaneous adverse event reports, serious adverse events and safety NCT 00823979 laboratory tests.; Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses (to be reported separately). Sponsor: Pfizer
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
CLINICAL TRIAL A Study to Assess the Tibotec, Inc. Clinical Trial To assess the influence of pregnancy on the pharmacokinetics of Pharmacokinetics (Blood Levels) of Recruiting: Daytona Beach, darunavir/ritonavir (darunavir/r) and/or etravirine during the second and TMC114 (Darunavir) Taken With Miami, Pensacola, Port St. third trimesters of gestation, as well as postpartum; Changes in anti-viral TMC114r (Ritonavir), and TMC125 Lucie, West Palm Beach, activity and safety and tolerability of darunavir/r and/or etravirine-based (Etravirine) in HIV-1 Infected Florida antiretroviral regimens during gestation and postpartum; compare Pregnant Women darunavir/r and/or etravirine concentrations between serum and cord blood; NCT00855335 [email protected] pregnancy outcome
CLINICAL TRIAL Optimizing Treatment for Treatment- National Institute of Allergy Time to regimen failure; Toxicity, as defined as time to first Grade 3 or Experienced, HIV-infected People and Infectious Diseases higher (and one grade higher than baseline) signs/symptom or laboratory NCT00537394 AIDS Clinical Trials Group abnormality; Tolerability, as defined as time to first dose modification, time to permanent discontinuation of all study drugs; Karen T. Tashima, MD, Time to abandoning randomized NRTI strategy; Time to virological failure, as Brown University; defined by the protocol; Binary variable indication if viral load is less than 50 copies/ml; Change in viral load; Binary variable indicating acquisition of Richard H. Haubrich, MD, drug resistance mutations to any of the study agents; Division of Infectious Diseases, Change in summarized quality of life score; Binomial indicator of "perfect" UCSD Antiviral Research Center adherence to assigned ARVs; Change in cardiovascular risk score and fasting This study is lipid values; Change in CD4 count; Time to serious non-AIDS events; Change in virus coreceptor tropism among those with R5-only tropic virus in ongoing, but not Step 1; HIV-1 co-receptor tropism; recruiting Binary indicator of undetectable CSF HIV-1 RNA; Summarized continuous neuro-cognitive performance Z-scores; Binary variable indicating whether participants. CSF ARV drug concentrations are above the population median; Responsible Party: CPE score (CNS penetration effectiveness) Rona Siskind, DAIDS
TMC125-TiDP2-C238: An Exploratory Tibotec Pharmaceuticals PK interaction between ETR and ATV/rtv at 2 different doses; safety & CLINICAL TRIAL Pharmacokinetics, Safety and Anti- Clinical Trial, IRELAND tolerability of ETR in combination with ATV/rtv and 1 NRTI over 48 weeks.; HIV Activity Study of Etravirine (ETR) Assessing the impact of cytochrome P450 (CYP) 2C9 and 2C19 genotypes on When Given With Boosted Atazanavir Recruiting: Orlando, Tampa, ETR PK; Evaluating safety and tolerability of ETR in combination with ATV/r (ATV/Rtv) at Two Different Doses and Vero Beach, West Palm Beach and 1 NRTI over 48 weeks; Evaluating the antiviral activity of ETR and ATV/r 1 Nucleoside Reverse Transcriptase This study is with 1 NRTI over 48 weeks; Evaluating the immunologic changes (as Inhibitor (NRTI) in Treatment measured by CD4 cells) with ETR and ATV/r with 1 NRTI over 48 weeks; Experienced HIV Patients ongoing, but not Evaluating changes in viral genotype and drug susceptibility NCT00896051 recruiting participants.
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Study to Evaluate the Safety and Alena Jandourek, M.D. Gilead The primary efficacy endpoint is the proportion of subjects who achieve HIV 1 CLINICAL TRIAL Efficacy of a Single Tablet Regimen of Sciences RNA < 50 copies/mL at week 48; The change from baseline in CD4 count in Emtricitabine/Rilpivirine/Tenofovir each treatment arm at week 48; The change from baseline in CD4 count in Disoproxil Fumarate Compared With This study is each treatment arm at week 96 a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir ongoing, but not Disoproxil Fumarate in HIV-1 recruiting Infected, Antiretroviral Treatment- Naïve Adults. participants NCT01309243
Safety of and Immune Response to an NATIONAL INSTITUTE OF Adverse events (AEs) of all grades; CLINICAL TRIAL H1N1 Influenza Vaccine in HIV ALLERGY AND INFECTIOUS AEs of all grades attributed to the study vaccine; Withholding of second BEHAVIORAL/EPIDEMIOLOGICAL Infected Pregnant Women DISEASES (NIAID) vaccine dose due to adverse reactions attributed to first dose; Immunologic NCT00992017 response, defined as hemagglutination inhibition (HAI) titer of at least 1:40; Study Chair: Sharon Nachman, Maternal immunologic response, defined as HAI of at least 1:40; The recruitment MD, State University of New Infant HAI of at least 1:40; Maternal geometric mean titers (GMT) of status of this study is York at Stony Brook antibodies HAI; Infant GMT of antibodies HAI; Maternal cell-mediated immunity (CMI) responses, as measured by B-cell and T-cell enzyme-linked unknown because Pfizer CT.gov Call Center immunosorbent spot (ELISPOT) assay values; CD4 count; the information has Contact: Carolyn Graisbery, RN HIV RNA copies/ml; Response to seasonal trivalent influenza vaccine (TIV); not been verified 727-767-8450 Exploration of factors related to HIV and its treatment that might affect the [email protected] response to H1N1 vaccinations recently Contact: Patricia Bryan 305-243-4447 [email protected] Principal Investigator: Gwendolyn B. Scott, MD
Contact: Kathleen Thoma, MPH 904-244-5331 [email protected]
Safety of and Immune Response to NATIONAL INSTITUTE OF Type-specific HPV antibody development from the seronegative status at CLINICAL TRIAL the Human Papillomavirus (HPV) ALLERGY AND INFECTIOUS baseline to seropositive status a month after the completion of HPV BEHAVIORAL/EPIDEMIOLOGICAL Vaccine in HIV-Infected Women DISEASES (NIAID); NATIONAL vaccination series (Week 28) for HPV types 6, 11, 16, and 18;
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
NCT00604175 INSTITUTE OF DENTAL AND Occurrence of Grade 3 or greater adverse events; CRANIOFACIAL RESEARCH HPV antibody titers to types 6, 11, 16, 18; This study is (NIDCR) Longitudinal changes in HIV viral load; Nadir and baseline CD4 count; ongoing, but not Baseline HIV viral load; Cellular immune response assay data from the Erna Milunka Kojic, MD, subset of U.S. participants; Longitudinal changes in CD4+ cell count from recruiting Department of baseline participants. Immunology/Infectious Disease, The Miriam Hospital, Brown University; Susan Cu-Uvin, MD, Obstetrics- Gynecology and Medicine, The Miriam Hospital, Brown University Study Chair: Erna Milunka Kojic, MD Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University
Study Chair: Susan Cu-Uvin, MD Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University
An Open Label Pharmacokinetic, VIIV Healthcare To determine the safety and tolerability of maraviroc in HIV-infected children CLINICAL TRIAL Safety And Efficacy Study Of and adolescents.; To determine the pharmacokinetic profile(s) and dosing Maraviroc In Combination With Pfizer CT.gov Call Center schedule(s) for maraviroc in treatment experienced HIV-infected children and Background Therapy For The Contact: Pfizer CT.gov Call adolescents on different background therapies;; Describe the efficacy of Treatment Of HIV-1 Infected, CCR5 Center 1-800-718-1021 multiple dose administration of maraviroc in treatment experienced children -Tropic Children infected with CCR5 tropic HIV-1;; Describe tropism changes over time. NCT00791700 Recruiting: Jacksonville, Miami, St. Petersburg, Tampa Safety and Effectiveness of NATIONAL INSTITUTE OF Termination from treatment due to suspected drug reaction attributable to CLINICAL TRIAL Raltegravir (MK-0518) in Treatment- ALLERGY AND INFECTIOUS the study medication; Grade 3 or 4 adverse events; BASIC SCIENCE/VIROLOGY Experienced, HIV-Infected Children DISEASES (NIAID) Pharmacokinetic parameters; HIV viral load; CD4 count and percentage; and Adolescents Genotypic and phenotypic resistance measures NCT00485264 Study Chair: Sharon A. Recruiting: Jacksonville, Miami, Ft. Lauderdale, Tampa Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 29 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Nachman, MD State University of New York at Stony Brook, Health Science Center Study Chair: Andrew Wiznia, MD Jacobi Medical Center, Albert Einstein College of Medicine Contact: Amy L Inman, BS 954-728-1050 [email protected] Contact: Zulma Eysallenne, R.N. 954-728-1125 [email protected] rg
Contact: Chas Griggs, MEd, CCRP 904-244-5331 [email protected] Principal Investigator: Mobeen H Rathore, MD
Contact: Liset Taybo, MD 305-243-4445 [email protected] Principal Investigator: Gwendolyn B. Scott, MD
Contact: Tammy A. Myers 813-259-8786 [email protected]
The TMC125-C214 Study Provides Study Director, Tibotec The purpose of this study is to provide early access of TMC125 to HIV-1 CLINICAL TRIAL Early Access to TMC125 for HIV-1 Pharmaceuticals Clinical Trial infected patients who have failed multiple antiretroviral (ARV) regimens. Infected Patients Who Have Failed Tibotec Pharmaceutical Information on safety and tolerability aspects of TMC125 in combination with Multiple Antiretroviral Regimens and Limited and IREL other ARVs in treatment-experienced HIV-1 patients with limited treatment Will Also Gather Information on the options will be assessed. Available data regarding the effectiveness of the Long-term Safety and Tolerability of This treatment drug will also be collected. To be eligible, patients should be failing their TMC125 Combined With Other current ARV regimen or be on a treatment interruption, should have has been Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 30 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Antiretroviral Drugs. approved for sale previously received 2 different protease inhibitor (PI) containing regimens NCT00354627 and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide to the public. reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications. CLINICAL TRIAL A Simplification Study of Unboosted GSK Clinical Trials and VIIV To determine the proportion of subjects who maintain HIV-1 RNA <50 Reyataz With Epzicom (ASSURE) Healthcare copies/mL through Week 24; Number of patients with adverse events as a measure of safety and tolerability in each treatment arm; To assess change from baseline in HIV-1 RNA and CD4+ cell count in each arm; To compare change from baseline in fasting lipid parameters (triglycerides, total cholesterol, LDL- and HDL-cholesterol) Pharmacokinetic Study of Anti-HIV NATIONAL INSTITUTE OF The purpose of this study is to determine what doses of anti-HIV medications CLINICAL TRIAL Drugs During Pregnancy ALLERGY AND INFECTIOUS are appropriate for pregnant women. BEHAVIORAL/EPIDEMIOLOGICAL DISEASES (NIAID); EUNICE Anti-HIV medication taken during pregnancy may control a woman's viral NCT00042289 KENNEDY SHRIVER NATIONAL load and reduce the chance that the baby will become infected with HIV. INSTITUTE OF CHILD HEALTH Pregnant women may require different doses of anti-HIV drugs than women AND HUMAN DEVELOPMENT who are not pregnant. This study will use pharmacokinetic (PK) sampling to (NICHD) determine what doses of anti-HIV medications are best for HIV-infected Mark Mirochnick, MD, Boston pregnant women and their infants. Medical Center
Contact: Emily F. Demske 301-628-3322
CLINICAL TRIAL Study to Evaluate Switching From John Flaherty, PharmD, Gilead The purpose of this study is to evaluate the non-inferiority of FTC/RPV/TDF Regimens Consisting of Ritonavir- Sciences fixed dose regimen (FDR) relative to regimens consisting of a ritonavir- boosted Protease Inhibitor (PI) and boosted protease inhibitor (PI/r)and two nucleoside reverse transcriptase Two Nucleoside Reverse This study is inhibitors (NRTIs). The FDR could offer an attractive treatment option to Transcriptase Inhibitors (NRTIs) to a patients who wish to simplify dosing by reducing pill burden or to improve Fixed Dose Tablet Containing ongoing, but not the tolerability of their treatment. Emtricitabine/Rilpivirine/Tenofovir DF recruiting NCT01252940 participants.
Responsible Party: Todd Fralich, MD, Director, Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 31 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Medical Affairs, Gilead Sciences
CLINICAL TRIAL Pregabalin Versus Placebo In The Pfizer CT.gov Call Center The purpose of this study is to evaluate the efficacy of pregabalin compared Treatment Of Neuropathic Pain to placebo in reducing neuropathic pain associated with HIV neuropathy. Associated With HIV Neuropathy Contact: Pfizer CT.gov Call NCT01049217 Center 1-800-718-1021 An Open-Label, Extension Safety Trial Pfizer CT.gov Call Center This study examines the safety of pregabalin over a 6 month period in CLINICAL TRIAL Of Pregabalin In Subjects With patients with neuropathic pain associated with HIV infection as an extension BEHAVIORAL/EPIDEMIOLOGICAL Neuropathic Pain Associated With Contact: Pfizer CT.gov Call of another trial that tests the efficacy of pregabalin. HIV Neuropathy (Pregabalin Center 1-800-718-1021 A0081251) NCT01145417
CLINICAL TRIAL A Randomized, Double-blind Study of Sherene Min, Project Physician ING111762 is a 48 week, randomized, double-blind, active-controlled, the Safety and Efficacy of Lead GSK Clinical Trials multicenter, parallel group, non-inferiority study. The study will be conducted GSK1349572 50 mg Once Daily SHIONOGI in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve Versus Raltegravir 400 mg Twice VIIV HEALTHCARE subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once Daily, Both Administered With an Contact: US GSK Clinical Trials daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator Investigator-selected Background Call Center selected background regimen consisting of at least one fully active agent plus Regimen Over 48 Weeks in HIV-1 877-379-3718 no more than one second single agent which may or may not be active. Infected, Integrase Inhibitor-Naïve, [email protected] Antiviral activity, safety, pharmacokinetics (PK), and development of viral Antiretroviral-Experienced Adults m resistance will be evaluated NCT01231516 High Dose Chemotherapy With Joseph Alvarnas, MD, City of This study is a Phase II, multicenter trial assessing overall survival after CLINICAL TRIAL Autologous Stem Cell Rescue for Hope National Medical Center autologous hematopoietic stem cell transplantation using a BEAM transplant BEHAVIORAL/EPIDEMIOLOGICAL Aggressive B Cell Lymphoma and Richard Ambinder, MD, Johns regimen in lymphoma patients with HIV. Hodgkin Lymphoma in HIV-infected Hopkins Medical Institution Patients (BMT CTN 0803) NATIONAL HEART, LUNG, AND University of Florida College of Medicine NCT01141712 BLOOD INSTITUTE (NHLBI); Gainesville, Florida, United States, 32610 NATIONAL CANCER INSTITUTE ( Contact: John Wingard, MD 352-273-8022
NCI); BLOOD AND MARROW [email protected] TRANSPLANT CLINICAL TRIALS H. Lee Moffitt Cancer Center NETWORK Tampa, Florida, United States, 33624 Contact: Ernesto Alaya, MD 813-745-1554 Contact: Mary Horowitz, MD, [email protected] MS 414-805-0700
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Perinatal Core Protocol Ruth Tuomala, MD, The purpose of this study is to collect and study clinical and laboratory CLINICAL TRIAL (Prenatal and Postnatal Studies of Director of Obstetrics and information about a pregnant or new mother and her medical care that will BEHAVIORAL/EPIDEMIOLOGICAL Interventions for Prevention of Gynecology, Brigham and increase our knowledge of the best care for HIV-infected pregnant women Mother-To-Child Transmission) Women's Hospital; Gwen and their children. Scott, MD, Pediatric Infectious The rate of transmission of HIV from mothers to their infants has gone down. NCT00028145 Diseases, University of Miami Specific U.S. Public Health Service guidelines recommend that HIV-infected School of Medicine pregnant women be treated with anti-HIV therapies; but the effectiveness of INTERNATIONAL MATERNAL treatment and safety for the mother and her infant have not been fully PEDIATRIC ADOLESCENT AIDS examined. This study will monitor the health of women and their infants CLINICAL TRIALS GROUP; while they receive anti-HIV therapy. Also, this study will provide information NAT’L INST. OF ALLERGY AND that may be used for future studies. INFECTIOUS DISEASES (NIAID); EUNICE KENNEDY SHRIVER Investigators NATIONAL INSTITUTE OF CHILD Study Chair: Ruth Tuomala, MD HEALTH AND HUMAN Director of Obstetrics and Gynecology, DEVELOPMENT (NICHD) Brigham and Women's Hospital
North Broward Hosp District Study Chair: Gwen Scott, MD Fort Lauderdale, Florida, 33311 Pediatric Infectious Diseases, Contact: Deanna Cruz University of Miami School of Medicine 954-728-1125 [email protected]
Univ of Florida Health Science Ctr / Pediatrics Jacksonville, Florida, 32209 Contact: Michelle Eagle 904-244-5331 [email protected]
Univ of Miami (Pediatric) Miami, Florida, 33136 Contact: Patricia Bryan 305-243-4447
Jackson Memorial Hosp Miami, Florida, 33136 Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 33 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Contact: Patricia Bryan 305-243-4447 [email protected]
University of South Florida at Tampa St Petersburg, Florida, Contact: Carolyn Graisbery, RN
727-892-4184 [email protected]
Emergency Use Program for Highly Boehringer Ingelheim To provide early access to tipranavir and evaluate the safety and tolerance of CLINICAL TRIAL Treatment-Experienced HIV+ Patients Pharmaceuticals tipranavir combined with low dose of ritonavir in patients with progressive, (Emergency Use Program for HTE HIV-1 disease who have failed or are intolerant to currently approved HIV+ Patients Who Need Tipranavir Contact: Boehringer Ingelheim treatments for HIV infection, who are unable to participate in another Treatment) Call Center tipranavir controlled clinical trial and have an urgent need for anti-HIV NCT00062660 1-800-243-0127 treatment. clintriage.rdg@boehringer- ingelheim.com
Connect To Protect® Partnerships for EUNICE KENNEDY SHRIVER Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a CLINICAL TRIAL Youth Prevention Interventions: NATIONAL INSTITUTE OF CHILD multi-site, three-phase project developed by the Adolescent Medicine Trials Phase III HEALTH AND HUMAN Network for HIV/AIDS Interventions (ATN). The overall goal of the project is DEVELOPMENT (NICHD); to ultimately reduce HIV incidence and prevalence in youth 12-24 years old NCT00271908 NATIONAL INSTITUTE ON through a community mobilization intervention. This protocol (ATN 040) DRUG ABUSE (NIDA); describes part one of Phase III. Part two of Phase III will be submitted as a NATIONAL INSTITUTE OF separate protocol (ATN 041). MENTAL HEALTH (NIMH); NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) Jonathan Ellen, MD,Johns Hopkins University Hospital This study has been completed as of 09-05-11
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
A Phase 1/2, Open Label, Single SANGAMO Biosciences This research study is being carried out to study a new way to possibly treat CLINICAL TRIAL Infusion Study of Autologous T-Cells Winson Tang, M.D., Sangamo human immunodeficiency virus (HIV). The agent is called SB-728-T which are Genetically Modified at the CCR5 BioSciences, Inc. CD4+ T-cells obtained from an individual that are genetically modified at the Gene by Zinc Finger Nucleases (SB- CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain 728-T) in HIV Infected Subjects Contact: Ya-Li Lee types of HIV to enter into and infect T-cells. T cells are one of the white blood NCT01252641 [email protected]: cells used by the body to fight HIV. The most important of these are called Shelley Wang, MD, Ph.D "CD4+ T-cells" [email protected] Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV. A Phase 2B Open Label Pilot Study to Alena Jandourek, MD, The purpose of this pilot study is to evaluate the efficacy and safety of CLINICAL TRIAL Evaluate Switching From a Regimen Gilead Sciences FTC/RPV/TDF STR after switching from EFV/FTC/TDF at baseline in Consisting of a maintaining HIV-1 RNA < 50 copies/mL at week 12. HIV-infected patients who Efavirenz/Emtricitabine/Tenofovir Alena Jandourek, MD, Dir, have been receiving EFV/FTC/TDF for greater than or equal to 3 months and Disoproxil Fumarate (EFV/FTC/TDF) Clinical Research, Gilead are experiencing safety or tolerability concerns (in particular, efavirenz- Single Tablet Regimen (STR) to Sciences related intolerance) may wish to change to an alternate, better tolerated Emtricitabine/Rilpivirine/Tenofovir regimen. Disoproxil Fumarate (FTC/RPV/TDF) NOT STR in Virologically Suppressed, HIV 1 CURRENTLY Infected Subjects NCT01286740 RECRUITING 10-06-11 Pilot Assessment of Abbott, This is a study to assess the response of lopinavir/ritonavir plus maraviroc CLINICAL TRIAL Lopinavir/Ritonavir and Maraviroc in Barry M. Rodwick, M. D. (with no nucleoside medications) in HIV patients failing their initial antiviral BASIC SCIENCE/VIROLOGY Experienced Patients therapy. NCT00981318 Contact: Barry M. Rodwick, M. D. 727-725-9931 [email protected]
727-725-9931
[email protected] Contact: Tiffany D. Ross, MA Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 35 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
CRC 727-725-9931 [email protected]
727-725-9931
Tiffany@DrRodwick. com
Intensive Pharmacokinetic Studies of Jennifer R. King, Pharm. D., This study will examine drug and body interactions in children receiving anti- CLINICAL TRIAL New Classes of Antiretroviral Drug U of A at Birmingham; HIV treatment regimens using new medications. Drug regimens to be Combinations in Children, Ram Yogev, MD, examined will feature the medications raltegravir (RAL), maraviroc (MVC), Adolescents and Young Adults Northwestern University and etravirine (ETV). These drugs will not be provided through the study. NCT00977756 Feinberg School of Medicine INTERNATIONAL MATERNAL Contact: Patricia Bryan 305-243- PEDIATRIC ADOLESCENT AIDS 4447 [email protected] CLINICAL TRIALS GROUP Principal Investigator: Charles D. NATIONAL INSTITUTE OF Mitchell, MD ALLERGY Contact: Tammy A. Myers 813-259- AND INFECTIOUS DISEASES 8786 [email protected] (NIAID) Contact: Zulma Eysallenne, R.N. 954-728-1125 [email protected]
A Multicenter, Single Arm, Open- Tibotec, Inc. Clinical Trial This study is a Phase II single arm, open-label, multicenter, study of 50 human CLINICAL TRIAL Label Study of the Once Daily immunodeficiency virus-1 (HIV) infected adult patients, all of whom will Combination of Etravirine and Responsible Party: Vice receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once Darunavir/Ritonavir As Dual Therapy President, Clinical Affairs, daily. This trial is designed to evaluate the efficacy of the aforementioned in Early Treatment-Experienced Tibotec, Inc ARV regimen, as measured by the percentage of patients with HIV RNA <50 Patients [email protected] copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also NCT01199939 assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
A 12-Week, Randomized, Double- KOWA RESEARCH INSTITUTE, A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group CLINICAL TRIAL Blind, Active-Controlled, Parallel- INC. Study. Group Study Comparing Pitavastatin Roger E Morgan, MD, FACS 4 mg vs. Pravastatin 40 mg in HIV- Infected Subjects With Dyslipidemia, Contact: Roger E Morgan, MD, Followed by a 40-Week Safety FACS 919-433-1600 Extension Study [email protected] NCT01301066 Safety and Immunogenicity of This observer-blind study will evaluate the safety and immunogenicity of CLINICAL TRIAL GlaxoSmithKline Biologicals' Herpes Contact: US GSK Clinical Trials GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine BASIC SCIENCE/VIROLOGY Zoster Vaccine 1437173A in Adult Call Center 877-379-3718 GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, HIV-infected Subjects [email protected] firstly enrolling subjects treated with antiretroviral therapy (ART) and with NCT01165203 m high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted section is exclusion criteria. Maraviroc Plus Darunavir/Ritonavir Principal Investigator: Jose The objective of this study is to evaluate the safety and efficacy of a novel CLINICAL TRIAL Study for Treatment-Naïve Patients Castro, M.D. (U of Miami); combination antiretroviral therapy regimen consisting of maraviroc plus BEHAVIORAL/EPIDEMIOLOGICAL Infected With R5-tropic HIV-1 Based Babafemi Taiwo, MD, darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. on Enhanced Sensitivity Trofile Northwestern University The hypothesis is that in treatment-naive subjects infected with R5-tropic PFIZER HIV-1, combination antiretroviral therapy with maraviroc plus NCT00993148 TIBOTEC, INC darunavir/ritonavir is well tolerated and efficacious. This study is ongoing, but not recruiting participants 10-06-11 Babafemi Taiwo, MD, Northwestern University (no contact information provided)
An Observer- and Subject-Blinded, GSK Investigational Site, A single dose escalation study to determine the safety, tolerability, and CLINICAL TRIAL Randomized, Placebo-Controlled, Daytona Beach, Florida pharmacokinetic profile of intramuscular and subcutaneous injections of Single Dose Escalation Study to VIIV Healthcare – Study GSK1265744 long acting parenteral (LAP) in healthy subjects. This study Investigate the Safety, Tolerability Sponsor consists of a screening visit, a single injection, and follow-up evaluations for a and Pharmacokinetics of This study is ongoing, but not minimum of 12 weeks following the injection. Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 37 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Intramuscular and Subcutaneous recruiting participants. Long Acting GSK1265744 in Healthy Responsible Party: Cheri Subjects Hudson; Clinical Disclosure NCT01215006 Advisor, GSK Clinical Disclosure (no contact information given)
A Phase II Trial of Response-Adapted M.D. Anderson Canter Center RATIONALE: Drugs used in chemotherapy work in different ways to stop the CLINICAL TRIAL Therapy of Stage III-IV Hodgkin at Orlando growth of cancer cells, either by killing the cells or by stopping them from BEHAVIORAL/EPIDEMIOLOGICAL Lymphoma Using Early Interim FDG- Recruiting dividing. Giving more than one drug (combination chemotherapy) may kill PET Imaging Orlando, FL more cancer cells. G-CSF may help lessen the side effects in patients receiving M.D. Anderson Cancer Center chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT NCT00822120 at Orlando, Florida, United imaging, may help doctors predict how patients will respond to treatment. States, 32806 PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging Contact: Julio J. to see how well it works in assessing response to combination chemotherapy Hajdenberg, MD 321- and allow doctors to plan better additional further treatment in treating 841-7219 patients with stage III or stage IV Hodgkin lymphoma.
Contact: Julio J. Hajdenberg, M.D. 321-841-7219 Southwest Oncology Group National Cancer Institute (NCI) A Randomized, Double Blind, Placebo- Email: The study is being done to find out the good and bad effects of an CLINICAL TRIAL Controlled, Parallel-Group, cahlstrom@southfloridamedicalr investigational drug that is not approved for sale to treat peripheral Multicenter Trial of An Investigational esearch.com neuropathic pain associated with HIV. The purpose is to see if the study drug Medication VS. Placebo in The Cheryl Ahlstrom, Patient relieves peripheral neuropathic pain associated with HIV. The study will also Treatment of Neuropathic Pain Liaison/Recruitment evaluate any side effects and whether or not they might be related to the Associated With HIV Neuropathy South Florida Medical Research study drug. Lastly, the study will assess whether patients will experience 21150 Biscayne Blvd , Suite 300 improvement in sleep , general health, and on symptoms of anxiety and Aventura, FL 33180 depression. There will be about 422 people in this study. You will be in the Phone: 305-931-8080 study for about 127 days. Fax: 305-931-8088 HIV-Neuropathy Study- Phase three Email:cahlstrom@southfloridam Men or women 18 years or older with documented evidence of HIV-1 CLINICAL TRIAL trial which lasts for 5 months with 12 edicalresearch.com infection who have distal symmetrical polyneuropathy with subjective visits for patients who suffer from Cheryl Ahlstrom, Patient Liaison sensory symptom of pain. (physician rated) neuropathic pain associated with HIV. South Florida Medical Research Pain started in the feet Phase 3B, randomized, double-blind, 21150 Biscayne Blvd, Suite 300 Must have moderate to severe neuropathy symptoms in the feet for at least placebo-controlled, parallel group, Aventura, FL 33180 3 months due to HIV neuropathy study of drug vs. a placebo in the Phone: 305-931-8080 Pain is constant every day Fax: 305-931-8088 Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 38 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
treatment of neuropathic pain HIV treatment is stable associated with HIV-1 infection. It is a 5 month, 12 visit study to compare the effects of the study medication to placebo. An International Observational Study UNIVERSITY OF MINNESOTA – The “flu” is a common disease and usually mild, but severe disease and death CLINICAL TRIAL to Characterize Adults Who Are CLINICAL AND TRANSLATIONAL may occur. There are several types of flu viruses and they change over time. BEHAVIORAL/EPIDEMIOLOGICAL Hospitalized With Complications of SCIENCE INSTITUTE Recently, a new influenza A virus known commonly as swine flu or H1N1v has Influenza A – Pandemic H1N1 NATIONAL INSTITUTE OF emerged. This flu has spread rapidly around the world. It is important to (H1N1v); NCT01056185 ALLERGY AND INFECTIOUS understand the course of illness for those who have H1N1v and the DISEASES (NIAID) characteristics of people who do not do well. The investigators will also try to NATIONAL INSTITUTES OF learn more about how different treatments and prior vaccination for the flu HEALTH (NIH) affects the course of the illness. Approximately 1,000 individuals will be Infectious Diseases Associates enrolled in several countries around the world. The results of this study will NW FL, PA be used to advise on the management of patients who are hospitalized with Pensacola, Florida, United States, 32504 the flu. Contact: Barbara He Wade, MD, FACP 850.476.3131 [email protected] Principal Investigator: Barbara He Wade, MD, FACP INSIGHT H1N1v Outpatient Study UNIVERSITY OF MINNESOTA - The "flu" is a common disease and usually mild but severe disease and deaths CLINICAL TRIAL (FLU 002) CLINICAL AND TRANSLATIONAL may occur. There are several types of flu viruses and they change over time. BEHAVIORAL/EPIDEMIOLOGICAL Official Title: An International SCIENCE INSTITUTE; Recently, a new influenza A virus known commonly as swine flu or H1N1v has Observational Study to Characterize NATIONAL INSTITUTE OF emerged. This flu has spread rapidly around the world. It is important to Adults With Influenza A – Pandemic ALLERGY AND INFECTIOUS understand the course of illness for those who have H1N1v and the H1N1 (H1N1v); NCT01056354 DISEASES (NIAID) characteristics of people who do not do well. The investigators will also try to NATIONAL INSTITUTES OF learn more about how different treatments and prior vaccination for the flu HEALTH (NIH) Infectious Diseases affect the course of the illness. Approximately 5,000 individuals with swine Associates NW FL, PA flu will be enrolled in several countries around the world. Not yet recruiting Pensacola, FL P.I.: Barbara Wade, M.D. Contact Barbara Wade, MD 850-476-3131 [email protected]
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
A Blinded, Randomized, Placebo- ABBOTT Contact: Christian A 12-week study of combination direct-acting antiviral agent (DAA) and CLINICAL TRIAL controlled, Dose Ranging Study to Naylor pegIFN/RBV in subjects with chronic HCV. Evaluate the Safety, Tolerability, (847) 935-2492 Pharmacokinetics, and Antiviral [email protected] Activity of Multiple Doses of ABT-450 Contact: Victoria M Mullally With Ritonavir (ABT-450/r), ABT-333 847-935-1406 or ABT-072 Each Administered Alone [email protected] Orlando area and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment- Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection NCT01074008 A Study of Danoprevir Boosted With HOFFMANN-LA ROCHE This randomized, open-label, active-controlled, parallel-group study will CLINICAL TRIAL Low Dose Ritonavir in Combination Recruiting Orlando and South evaluate the sustained virological response of danoprevir boosted with low With Pegasys and Copegus in Miami, FL dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Treatment-Naive Patients With Study ID #: NV22776 Copegus versus Pegasys and Copegus alone in treatment-naive patients with Chronic Hepatitis C Virus Infection 888-662-6728 (U.S. only) chronic Hepatitis C NCT01220947 Genentechclinicaltrials@druginf o.com Isotretinoin With or Without Numerous locations throughout RATIONALE: Drugs used in chemotherapy work in different ways to stop CLINICAL TRIAL Monoclonal Antibody, Interleukin-2, Florida tumor cells from dividing so they stop growing or die. Monoclonal antibodies BEHAVIORAL/EPIDEMIOLOGICAL and Sargramostim Following Stem CHILDREN'S ONCOLOGYGROUP; can locate tumor cells and either kill them or deliver tumor-killing substances Cell Transplantation in Treating NATIONAL CANCER to them without harming normal cells. Interleukin-2 and sargramostim may Patients With Neuroblastoma INSTITUTE (NCI) stimulate a person's white blood cells to kill cancer cells. It is not yet known if Under 30 yrs old chemotherapy is more effective with or without monoclonal antibody Official Title: Phase III Randomized therapy, interleukin-2, and sargramostim following stem cell transplantation Study Chair: Study Of Chimeric Antibody 14.18 in treating neuroblastoma. Alice L. Yu, M.D., Ph.D. PURPOSE: Randomized phase III trial to compare the effectiveness of (CH14.18) In High Risk UC at San Diego (no contact chemotherapy with or without monoclonal antibody, interleukin-2, and Neuroblastoma Following information provided) Myeloablative Therapy And sargramostim following stem cell transplantation in treating patients who Autologous Stem Cell Rescue Gregory H. Reaman, Children's have neuroblastoma NCT00026312 Oncology Group - Group Chair Office Study on The Combination of HOFFMAN-LA ROCHE This multicenter, randomized, double-blind, parallel group study will evaluate CLINICAL TRIAL RO5024048 And Ritonavir-Boosted the safety and efficacy of the combination RO5024048 and ritonavir-boosted Danoprevir With And Without Will be recruiting in Orlando, FL danoprevir with and without Copegus (ribavirin) in patients with chronic Copegus (Ribavirin) in Interferon- hepatitis C genotype 1 who are treatment-naïve for interferons. Patients will Naïve Patients With Chronic Hepatitis Please reference Study receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with C Genotype 1 (INFORM-SVR) ID # PP25213 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg Rev. 12/06/11 FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 40 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Official Title: INFORM-SVR: A 888-662-6728 orally daily) or placebo for 12 weeks. Depending on viral response, the Randomized, Multi-Center Study of genentechclinicaltrials@druginfo assigned treatment will be continued for a further 12 weeks. The anticipated Interferon-Free Treatment With a .com time on study treatment is up to 24 weeks plus a 24-week follow-up Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients NCT01278134 COMMUNITY AIDS NETWORK, SARASOTA, FL TANYA SCHREIBMAN, M.D., MEDICAL DIRECTOR
CLINICAL TRIAL Title: A pilot randomized, open-label Site Investigator: Tanya Study primary site is Yale HIV, antiretroviral therapy study comparing the safety and Schreibman, M.D. (PI is Yale University with our site efficacy of a Raltegravir based NRTI based: Michael Kozal, MD) (Community AIDS sparing regimens "No Nukes Study". Community AIDS Network Network/Comprehensive 941-366-0134 Care Clinic) as a satellite site
ORLANDO IMMUNOLOGY CENTER, ORLANDO, FL EDWIN DEJESUS, M.D., MEDICAL DIRECTOR
This is a multicenter, open-label, non-randomized, dual-arm pilot study CLINICAL TRIAL Title: Evolution of L74V or K65R Study Director: Edwin to investigate the prevalence of the reverse transcriptase (RT) Mutations in Vlremic Subjects on TDF or Dejesus, MD, FACP resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects ABC (EVITA) (407) 647-3960 experiencing confirmed first-time incomplete virologic suppression during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times. Subjects will have a screening genotype to establish adherence to their
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized. Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.
TOTAL NUMBER OF CLINICAL TRIAL STUDIES LISTED AS OF 12/06/11 = 163
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
BEHAVIORAL/EPIDEMIOLOGICAL STUDIES
BEHAVIORAL/EPIDEMIOLOGICAL The Impact of HIV/AIDS among Dr. Ramiro Martinez (PI) School of Criminology HIV/AIDS and Latina/o Suicide Victims Latina/o Suicide Victims Funding Source: NIMHD (completed)
BEHAVIORAL/EPIDEMIOLOGICAL HIV and Substance Abuse Risk Dr. WayWay M. Hlaing School of Social Work HIV, Substance Abuse, Risk Behaviors, and Behaviors Among Hispanic Youth (PI) Hispanic Youth of Florida of Florida (completed) Funding Source: NIMHD
Rev. 12/06/11 BEHAVIORAL/EPIDEMIOLOGICAL Impact of 2005 Hurricane Season Dr. Sukumar Ganapati School of Social Work 2005 Hurricane Season, HIV/ AIDS, and on HIV/ AIDS Health Services in Health Services in Miami Dade County Miami Dade County (Completed) Funding Source: NIMHD FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) BEHAVIORAL/EPIDEMIOLOGICAL Latino Minority Drug Abuse Dr. Mario De La Rosa (PI), School of Social Work intergenerational transmission of drug use, Research Center: WomenINVENTORY Study OFDr. HIV/AIDSPatria Rojas RESEARCH IN FLORIDA Risky sexual behaviors, Latino women (Completed) (mother-daughter dyadsPage 43 of 48 Funding Source: NIDA HIV Infection and Risk of Fatal Dr. Ramiro Martinez CRUSADA HIV Infection, Risk of Fatal Drug Overdose BEHAVIORAL/EPIDEMIOLOGICALSTUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA Drug Overdose in Miami in Miami Communities Communities: An Individual and Funding Source: NIMHD Community Level Analysis (Completed) BEHAVIORAL/EPIDEMIOLOGICAL Clusters and Trends of Sexual, WayWay Hlaing, Sunny CRUSADA Clusters and Trends of Sexual, Substance Substance Use, and Other Health Kim, Mario De La Rosa Use, and Other Health Risks and Hispanic Risks among Hispanic and Non- and Non-Hispanic Adolescents Hispanic Adolescents (Completed) Funding Source: NIMHD BEHAVIORAL/EPIDEMIOLOGICAL HIV Risk Reduction In High Risk Dr. Jesus Sanchez CRUSADA HIV Risk Reduction and Risk Hispanic Hispanic Migrant Workers In Migrant Workers In South Florida Funding South Florida (Completed) Source: NIMHD
BEHAVIORAL/EPIDEMIOLOGICAL HIV Risk Behavior and Substance Mario De La Rosa (PI), CRUSADA HIV Risk Behavior and Substance Abuse, Abuse among Recent Latino Patria Rojas recent Latino Immigrants Funding Source: Immigrants (ongoing) NIMHD
BEHAVIORAL/EPIDEMIOLOGICAL A Longitudinal Study of Substance Mario De La Rosa (PI), CRUSADA Substance use, HIV risk behavior Abuse and HIV Risk Among Patria Rojas, Frank Dillon trajectories, Latina mothers and daughters Adult Latina Mother-Daughter Funding Source: NINR (ongoing) BEHAVIORAL/EPIDEMIOLOGICAL Retrospective cohort study to Mary Jo Trepka (PI), Epidemiology and To estimate the effect of community-level estimate the contribution of Theophile Niyonsenga, Biostatistics (and FDOH) deprivation and rural residence on racial socioeconomic status, Spencer Lieb, Lorene disparities in HIV survival over time segregation and rural residence Maddox To estimate the effect of racial segregation on racial disparities in HIV on HIV survival survival, Florida To characterize changes in community- level socioeconomic status between the time of AIDS diagnosis and death To compare the degree of community racial segregation between the time of AIDS diagnosis and death To characterize patterns and predictors of rural to urban migration between AIDS diagnosis and death Funded by The NCMHHD Trajectories of Drug Abuse and Mario De La Rosa (PI), CRUSADA Substance abuse, HIV/AIDS, health BEHAVIORAL/EPIDEMIOLOGICAL Impact of 2005 Hurricane Dr. Sukumar Ganapati School of Social 2005 Hurricane Season, HIV/ AIDS, and Health HIVSeason Risk onamong HIV/ LatinoAIDS Health Father-Son Frank Dillon, Patria Rojas Work Servicesdisparities, in Miami Latino Dade menCounty Funding Source: DyadsServices (Planned) in Miami Dade County FundingNINR Source: NIMHD (Completed) Rev. 12/06/11
BEHAVIORAL/EPIDEMIOLOGICAL Serotonin and Brain Derived Investigators: Maria Jose CRUSADA Serotonin and Brain Derived Neurotrophic, Neurotrophic Factor Roles on HIV Miguez (PI), Mario De La HIV Risk Behaviors, Latino Mother- Risk Behaviors on Latino Mother- Rosa, Robert Malow, Adolescent Dyads FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR) INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA Page 44 of 48
STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
BEHAVIORAL/EPIDEMIOLOGICAL Medical Monitoring Project Grigg, Becky L PhD Supplemental HIV/AIDS Persons receiving HIV medical care in public Surveillance and private facilities in Florida.
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Protocol Title: TLC-Plus: A BEHAVIORAL/EPIDEMIOLOGICAL PI: Becky Grigg, PH.D, Funded By: Fred Hutchinson Cancer Study to Evaluate the Florida Dept. of Health, Research Center, Feasibility of an Enhanced Test, Bureau of HIV/AIDS, Plus 0000698642 National Institute of Link to Care, Plus Treat Surveillance Child Health and Human Development Approach for HIV Prevention in (NICHD) the United States
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
TOTAL NUMBER OF BEHAVIORAL STUDIES LISTED AS OF 12/06/11 = 160
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
STATE BUREAU OF LABORATORIES – 5 Studies Presenter: Berry Bennett, M.P.H.
BASIC SCIENCE/VIROLOGY (Planned) Implementation of a B. Bennett (PI), D. Willis, Retrovirology, Jacksonville Laboratory/Patient Care – HIV-1 acute 4th Generation HIV-1/2 Ag/Ab M. Salfinger, M. Diamante & Miami infection detection and the Screening assay and a Non- implementation of a new HIV diagnostic Traditional Confirmatory algorithm Process BASIC SCIENCE/VIROLOGY Correlation on the Use of a Bennett B (PI), Fordan S, Retrovirology, Jacksonville Laboratory Reactive Signal to Cutoff Diamante M, et.al. & Miami Threshold Value in a 3rd Generation HIV-1/2 Antibody Immunoassay to Expedite Supplemental Testing and Reduce Screening Costs. Poster, 2010 HIV Diagnostic Conference, March 2010, Orlando BASIC SCIENCE/VIROLOGY Performance of the Aptima HIV- Ethridge S (PI), Bennett, B, Retrovirology, Jacksonville Laboratory 1 RNA Qualitative Assay with Stephens, P, et.al. & Albany; CDC and NYDOH 16- and 32-Member Specimen LABORATORY Pools. Journal of Clinical Microbiology, Vol. 48, No. 9, Sept. 2010, p. 3343-3345 BASIC SCIENCE/VIROLOGY Cost-Effectiveness of Pooled Hutchinson A (PI), Bennett Retrovirology, Jacksonville Laboratory Nucleic Acid Amplification B, et.al. & Albany; CDC and Testing for Acute HIV Infection NYDOH LABORATORY after Third-Generation HIV Antibody Screening and Rapid Testing in the United States: A Comparison of Three Public Health Settings. PLoS Medicine, Vol. 7, Issue 9, Sept. 2010, e1000342 BASIC SCIENCE/VIROLOGY Detecting Acute Human Patel P (PI), Bennett B, Retrovirology, Jacksonville Laboratory/Prevention
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STUDY CATEGORY PROJECT TITLE INVESTIGATORS DEPARTMENT SCIENTIFIC AREA
Immunodeficiency Virus Lalota M, Simmons P, & Albany; Prevention Infection Using 3 Different et.al. Program; CDC and NY Screening Immunoassays and LABORATORY Nucleic Acid Amplification Testing for Human Immunodeficiency Virus RNA, 2006-2008, Archives of Internal Medicine, Vol 170 (#1), Jan. 11, 2010
TOTAL NUMBER OF BASIC SCIENCE STUDIES LISTED AS OF 9/30/11 = 91
GRAND TOTAL NUMBER OF STUDIES LISTED AS OF 12/06/11 = 414
Rev. 12/06/11