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Trichomonas Vaginalis Repeat Infections Among HIV-Negative Women

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Trichomonas Vaginalis Repeat Infections Among HIV-Negative Women Trichomonas vaginalis repeat infections among HIV-negative women NIAID Protocol Number: 12-0058 Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) NIAID Funding Mechanism: TBA Pharmaceutical Support Provided by: N/A Other Identifying Numbers: IND Sponsor: N/A IND # 118276 Principal Investigator/Protocol Chair: Patricia Kissinger, Ph.D. NIAID Medical Monitor: TBA Draft or Version Number: 11 Day Month Year 2nd of January, 2017 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from NIAID (or others, as applicable), unless it is necessary to obtain informed consent from potential study participants. Version: 11.0 Version date: 1/2/17 Statement of Compliance This trial will be conducted in compliance with the protocol and the Tulane University biomedical IRB. The Administrators of The Tulane Educational Fund through the Tulane University Biomedical IRB (FWA #00002055) is duly constituted, organized and operates in compliance with DHHS regulations as described in 45 CFR part 46, i.e. The Common Rule, FDA regulations as described in 21 CFR Parts 50 and 56. Tulane’s Biomedical IRB also complies with the guidelines resulting from the International Conference on Harmonization (ICH) E-6 Good Clinical Practice guidelines as required to the extent required by third-party sponsors. In addition, the Tulane University IRB operates in compliance with portions of the Health Insurance of Portability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164 as appropriate. All investigators and staff will have completed the protection of Human Subjects Training as required by the participating institutions and will adhere to all NIAID Clinical Terms of Award. Version: 11.0 Version date: 1/2/17 ii Signature Page 1 The signature below constitutes the approval of this protocol and the attachments, and provides the necessary assurances that this trial will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable U.S. federal regulations and ICH guidelines. The Lead Principal Investigator (Protocol Chair) should sign Signature Page 1. A copy of this Signature Page 1 should be filed with the holder of the Regulatory documents and a copy should be maintained at the site. Version: 11.0 Version date: 1/2/17 iii Signature Page 2 The signature below constitutes the approval of this protocol and the attachments, and provides the necessary assurances that this trial will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable U.S. federal regulations and ICH guidelines. The Investigator(s) of Record (signature(s) on 1572) from each participating clinical site should sign he Signature Page 2 as appropriate. This Signature Page 2 should be maintained at each site Version: 11.0 Version date: 1/2/17 iv NIAID Protocol Template Version 2.0 (Extra) Extramural Guidance 16 July 2008 Table of contents STATEMENT OF COMPLIANCE ...........................................................................................................................II SIGNATURE PAGE 1 ............................................................................................................................................. III SIGNATURE PAGE 2 ............................................................................................................................................. IV LIST OF ABBREVIATIONS ................................................................................................................................ VIII PROTOCOL SUMMARY .......................................................................................................................................... X 1. KEY ROLES ....................................................................................................................................................... 1 2. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ........................................................... 5 2.1 BACKGROUND INFORMATION ............................................................................................................................. 5 2.1.1 Description of the Study Agent(s)/Intervention(s) ............................................................................ 6 2.1.2 Summary of Previous Pre-clinical Studies ........................................................................................ 6 2.1.3 Summary of Relevant Clinical Studies ............................................................................................... 7 2.1.4 Summary of Epidemiological Data ..................................................................................................... 8 2.2 RATIONALE ......................................................................................................................................................... 9 2.3 POTENTIAL RISKS AND BENEFITS .................................................................................................................... 14 2.3.1 Potential Risks ........................................................................................................................................ 14 2.3.2 Potential Benefits ................................................................................................................................... 16 3. STUDY OBJECTIVES..................................................................................................................................... 17 3.1 PRIMARY OBJECTIVE........................................................................................................................................ 17 3.2 SECONDARY OBJECTIVES ................................................................................................................................ 17 3.3 EXPLORATORY OBJECTIVES ............................................................................................................................ 17 4. STUDY DESIGN .............................................................................................................................................. 17 4.1 DESCRIPTION OF THE STUDY DESIGN .............................................................................................................. 17 4.2 STUDY ENDPOINTS ........................................................................................................................................... 18 4.2.1 Primary Endpoint .................................................................................................................................... 18 4.2.2 SECONDARY ENDPOINTS .............................................................................................................................. 18 4.2.3 EXPLORATORY ENDPOINTS .......................................................................................................................... 18 4.2.4 SUBSTUDY ENDPOINTS ................................................................................................................................. 18 5. STUDY POPULATION .................................................................................................................................... 18 5.1 DESCRIPTION OF THE STUDY POPULATION ..................................................................................................... 18 5.1.1 Participant Inclusion Criteria .............................................................................................................. 19 5.1.2 Participant Exclusion Criteria ............................................................................................................ 19 5.2 STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................................... 19 6. STUDY AGENT/INTERVENTIONS .............................................................................................................. 19 6.1 STUDY AGENT ACQUISITION ............................................................................................................................ 20 6.1.1 STUDY AGENT/INTERVENTION # 1 -- Metronidazole ................................................................ 20 6.1.1.1 Formulation, Packaging, and Labeling .......................................................................................................... 20 6.1.2 Co-enrollment Guidelines .................................................................................................................. 20 6.1.3 Preparation, Administration, Storage, and Dosage of Study Agent(s)/Intervention(s) ............. 20 6.1.1.3 Study Agent Accountability Procedures .................................................................................................. 20 6.1.4 STUDY AGENT/INTERVENTION #2 ............................................................................................... 21 6.2 ASSESSMENT OF PARTICIPANT COMPLIANCE WITH STUDY AGENT(S)/INTERVENTION(S) ............................. 21 6.3 CONCOMITANT MEDICATIONS AND PROCEDURES .........................................................................................
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