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Alternative Delivery Strategies for Hiv Prevention & Treatment

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Alternative Delivery Strategies for Hiv Prevention & Treatment ALTERNATIVE DELIVERY STRATEGIES FOR HIV PREVENTION & TREATMENT by Ethel D. Weld, MD A dissertation submitted to Johns Hopkins University in conformity with the requirements for the degree of Doctor of Philosophy Baltimore, Maryland April 2019 Abstract The three parts of this thesis are as follows: 1) A comparative pre-phase I study exploring the impact of volume of microbicide gel vehicle on distribution through the distal colon, user experience, and acceptability (Section II); 2) An analysis of the colorectal distribution of lymphocytes and cell-free HIV surrogate in autologous seminal plasma following simulated anal intercourse (Section III); and 3) A survey study exploring the interest of U.S. youth living with HIV in long-acting injectable antiretrovirals (Section IV). Section II: Methods: Eight HIV negative men with a history of recent RAI were enrolled into a two- period, sequence randomized, dosing study comparing 3.5 mL and 10 mL of radiolabeled (1 mCi 99mTc-DTPA) universal placebo hydroxyethyl cellulose (HEC) gel. Each participant received two doses in the research unit, one of each volume, separated by a washout period of at least 2 weeks. Each research unit dose was followed by a self-administered take-home dose. Safety and gastrointestinal distribution were assessed after the research unit doses; safety, perceptibility, and acceptability were assessed after take-home doses. Results: There were no adverse effects of Grade 2 or higher and all resolved spontaneously. Both volumes were well tolerated and received high acceptability scores. The 3.5 mL and 10 mL gel volumes distributed similarly (p>0.2) within the rectosigmoid. Both volumes covered the typical gastrointestinal distribution of ejaculate following simulated intercourse based on other studies. Conclusion: Either of these gel volumes could reasonably be pursued for the next phase of development of rectal microbicides. Section III: Objective: The objective of this study was to explore the luminal distribution and clearance of cell-associated (lymphocytes) and cell-free (seminal plasma) HIV surrogates within the distal colon following simulated receptive anal intercourse. Methods: Six healthy, HIV- uninfected men gave semen samples in sterile containers. Samples were centrifuged and the supernatant (seminal plasma) collected and frozen. Peripheral blood lymphocytes were harvested ii from subjects via apheresis and labeled with 111Indium (In)-oxine on the dosing day. 111In-labeled autologous lymphocytes and 99Technetium (Tc)-sulfur colloid (HIV surrogate) were reconstituted with 3 mL of autologous seminal plasma. Reconstituted seminal plasma was inserted into the rectum using a phallic device with artificial urethra. Distribution of radiolabels in time and space was assessed with SPECT/CT at 3 timepoints. Analysis of radiolabel distribution was performed using a flexible principal curve algorithm in R. Pharmacokinetic distance parameters were defined. Results: Median (interquartile range (IQR)) PK distance paarameters for cell-associated (In) and cell-free (Tc) HIV surrogate were described; distribution was similar between cell-free and cell- associated HIV surrogate. Conclusions: Both autologous lymphocytes and HIV surrogate particle in seminal plasma distribute to a maximal distance of around 15 cm from the anorectal junction (which is ~19 cm from the anal verge), with a maximal signal intensity around 6 cm from the anorectal junction. This represents and maps the ideal target distribution for rectal microbicides. Section IV: Objectives: This study aimed to characterize attitudes to long-acting antiretrovirals (LAARV), among youth aged 13 to 24 years living with perinatally- and non-perinatally-acquired HIV (PHIV and NPHIV, respectively). Methods: A cross-sectional survey of 303 Youth Living with HIV (YHIV) followed at four pediatric/adolescent HIV clinics in the USA was performed. Findings: Overall, 88% of YHIV reported probable or definite willingness to use LAARV. The enthusiasm level was similar between PHIV and NPHIV youth (p=0.93). Youth with HIV viral load >1000 copies/mL had significantly higher interest than youth with suppressed viral load (PR 1.12 [95% CI: 1.03 - 1.20]; p= 0.005). Proportion of respondents endorsing definite willingness to use was significantly higher with decreased injection frequency compared to increased injection frequency. Conclusions: YHIV at four urban US pediatric/adolescent HIV clinics had high levels of enthusiasm for LAARV. LAARV should be given high priority as a potentially viable treatment option to improve clinical outcomes in YHIV. iii Dissertation Readers Brian Caffo (committee chair), Craig Hendrix (thesis advisor), Diane Griffin (academic advisor), Khalil Ghanem, David Levine iv Preface “One of the first duties of the physician is to educate the masses not to take medicine.” --W. Osler v Acknowledgments All thanks are due to my mentors Craig Hendrix and Allison Agwu for their patient and wise guidance throughout my time in the GTPCI program, and for helping me to develop the work and ideas contained in this thesis. My gratitude also goes to the GTPCI program leadership and administrators for their calm stewardship over the years. The participants in these challenging studies devoted their time, vital resources and energies to the project of expanding scientific understanding, and have thus earned my profound gratitude. Love and thanks to MDEMQF, T, S, and s, who have given me their unflinching fandom and love, have sat companionably with me through many long nights and Grape-Nuts moments, and some of whom even went so far as to attend my thesis defense in a Derby hat. vi Table of Contents Section I: Introduction………………………………………………………..……………….Page 1 Section II: A Comparative Pre-Phase I Study of the Impact of Gel Vehicle Volume on Distal Colon Distribution, User Experience, and Acceptability…………………………………….………...…4 Section III: Colorectal Distribution of Lymphocytes and Cell-Free HIV Surrogate in Autologous Seminal Plasma Following Simulated Anal Intercourse…………………………………….……25 Section IV: Interest of Youth Living with HIV in Long-Acting Antiretrovirals…………….…..44 Section V: Overall Thesis Conclusions………………………………………………………...…73 References: Appendices………………………………………………………………………………………...76 Bibliography……………………………………………………………………………………….94 Curriculum Vitae…………………………………………………………………………………104 vii List of Tables Table IIa. Summary of Adverse Events…………………………………………………….…..…..13 Table IIb. Averaged Perceptibility (User Sensory Perception and Experience (USPE)) Scale Item Scores, Standard Deviations, Cronbach’s Coefficient Alphas (CCA), Cohen’s Effect Sizes (d), and p-values for Low- and High-volume Gel Comparisons……………………………………....……15 Table IIIa. Pharmacokinetic Distance Parameters for Distribution of 111In-Labeled Lymphocytes and 99Tc-labeled HIV Surrogate Particle Through Colorectal Space…………..…….…..……..….35 Table IIIb. P-values (direction of difference) for comparison of PK Distance Parameters by Timepoint………………………………………………………………………………………….36 Table IVa. Baseline Characteristics Stratified by Mode of Acquisition of HIV…………………...52 Table IVb. Crude and adjusted Prevalence Ratio (PR) and 95% Confidence Interval of the interest level in Intramuscular LAARV by Poisson Regression with robust variance…………………..…54 Table IVc. Female participants’ willingness to try IM and implantable LAARV based on past experience with contraceptive technologies…………………..…………………………………..59 viii List of Figures Figure IIa: Study Schema………………………………………………………………………..…..9 Figure IIb. Pharmacokinetic distance parameters for two volumes (3.5 mL and 10 mL) of HEC gel delivered through applicator……………………………………………………………….…....…18 Figure IIIa. Distance Parameters Versus Time for Cell-Associated and Cell-Free HIV Surrogates…………………………………………………………………………………….…….37 Figure IVa. Youth Preference for Intramuscular over Subdermal Implantable LAARV…….……53 Figure IVb. Adjusted Prevalence Ratio of High Interest in LAARV By Participant Characteristics……………………………………………………………………………………...56 Figure IVc. Comparison of Interest in LAARv by Various Characteristics………………..…..….57 Figure IVd.1: Gradient of Definite or Probable Willingness to Use Increases with Decreased Injection Frequency………………………………………………………………….……………..60 Figure IVd.2: Proportion of Definite Willingness to Use Is Higher with Decreased Injection Frequency Compared to Increased Injection Frequency…………………………………………...61 ix Section I: Introduction The broad significance of this research to medicine is that it lays the groundwork for new dosing and delivery approaches for the biomedical prevention and treatment of HIV while directly tackling the problem of poor adherence to biomedical interventions—the Achilles heel of even the most dazzling, painstakingly conceived and researched, and life-saving of technologies. (1) In the words of former U.S. Surgeon General C. Everett Koop, “drugs don’t work in patients who don’t take them.” (2) Non-adherence (not taking medications as prescribed, or not taking prescribed medicines at all) has been called “America’s other drug problem”, and is estimated to be responsible for $300 billion in avoidable health care costs and 125,000 preventable deaths yearly. (3) Non-adherence to HIV biomedical prevention technologies such as pre-exposure prophylaxis (PrEP) leads to HIV acquisition in certain risk settings, and in the realm of HIV treatment, now that treatment as prevention is a better understood prevention strategy, non-adherence leads not only to potentially disastrous consequences
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