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MTN-034 Study Protocol MTN-034 A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population Microbicide Trials Network Funding Agencies: Division of AIDS, US National Institute of Allergy and Infectious Diseases US Eunice Kennedy Shriver National Institute of Child Health and Human Development US National Institute of Mental Health US National Institutes of Health Grant Numbers: UM1AI068633, UM1AI068615, UM1AI106707 DAIDS Protocol ID: 12066 IND Sponsor: DAIDS IND #: TBD Pharmaceutical Company Collaborators: Gilead Sciences, Inc. International Partnership for Microbicides Protocol Chair: Gonasagrie Nair, MBChB, MPH Protocol Co-Chairs: Connie Celum, MD, MPH Kenneth Ngure, PhD Version 2.0 December 7, 2017 MTN-034 A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population TABLE OF CONTENTS TABLE OF CONTENTS .............................................................................................................................................. 2 LIST OF ABBREVIATIONS AND ACRONYMS ............................................................................................................. 7 PROTOCOL TEAM ROSTER .................................................................................................................................... 11 PROTOCOL SUMMARY ......................................................................................................................................... 24 KEY ROLES ......................................................................................................................................... 28 PROTOCOL IDENTIFICATION ............................................................................................................................. 28 SPONSOR AND MONITOR IDENTIFICATION ......................................................................................................... 28 MEDICAL OFFICER ......................................................................................................................................... 29 CLINICAL LABORATORIES................................................................................................................................. 29 DATA CENTERS ............................................................................................................................................. 29 STUDY OPERATIONS ...................................................................................................................................... 30 INTRODUCTION ................................................................................................................................. 31 MICROBICIDES AND ORAL PREP IN HIV/AIDS PREVENTION .................................................................................. 31 DESCRIPTION ............................................................................................................................................... 33 2.2.1 Dapivirine Vaginal Ring (VR) ................................................................................................................ 33 2.2.2 FTC/TDF Tablet..................................................................................................................................... 34 MECHANISM OF ACTION ................................................................................................................................ 36 2.3.1 Dapivirine Vaginal Ring (VR) ................................................................................................................ 36 2.3.2 FTC/TDF Tablet..................................................................................................................................... 36 STRENGTH OF STUDY PRODUCTS ...................................................................................................................... 36 2.4.1 Dapivirine Vaginal Ring (VR) ................................................................................................................ 36 2.4.2 FTC/TDF Tablet..................................................................................................................................... 36 NONCLINICAL STUDIES ................................................................................................................................... 36 2.5.1 In vitro Studies of Dapivirine ................................................................................................................ 36 2.5.2 In vitro studies of Emtricitabine (FTC) and Tenofovir Disoproxil Fumarate (TDF) in Combination ....... 39 CONDOM COMPATIBILITY STUDIES (DAPIVIRINE GEL) .......................................................................................... 39 CLINICAL STUDIES ......................................................................................................................................... 40 2.7.1 Clinical Studies of Dapivirine Vaginal Rings ......................................................................................... 40 2.7.2 Clinical Studies of FTC/TDF Tablet (Truvada®) ..................................................................................... 48 PREVALENCE OF PRIMARY NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) AND NRTI RESISTANCE MUTATIONS................................................................................................................................................. 54 2.8.1 Dapivirine Vaginal Ring (VR) ................................................................................................................ 54 2.8.2 FTC/TDF Tablet..................................................................................................................................... 56 BEHAVIORAL STUDIES .................................................................................................................................... 56 2.9.1 Acceptability and Adherence: Dapivirine VR ........................................................................................ 56 2.9.2 Acceptability and Adherence: FTC/TDF Tablet as PrEP ........................................................................ 58 RATIONALE FOR STUDY DESIGN ....................................................................................................................... 62 MTN-034, Version 2.0 2 December 7, 2017 OBJECTIVES ....................................................................................................................................... 63 PRIMARY OBJECTIVES .................................................................................................................................... 63 SECONDARY OBJECTIVES................................................................................................................................. 63 EXPLORATORY OBJECTIVES .............................................................................................................................. 63 STUDY DESIGN .................................................................................................................................. 64 IDENTIFICATION OF STUDY DESIGN ................................................................................................................... 64 SUMMARY OF MAJOR ENDPOINTS .................................................................................................................... 64 DESCRIPTION OF STUDY POPULATION ............................................................................................................... 65 TIME TO COMPLETE ACCRUAL ......................................................................................................................... 65 EXPECTED DURATION OF PARTICIPATION ........................................................................................................... 65 SITES .......................................................................................................................................................... 66 STUDY POPULATION ......................................................................................................................... 66 SELECTION OF THE STUDY POPULATION ............................................................................................................. 66 5.1.1 Recruitment ......................................................................................................................................... 66 5.1.2 Retention.............................................................................................................................................. 66 INCLUSION CRITERIA ...................................................................................................................................... 66 EXCLUSION CRITERIA ..................................................................................................................................... 67 CO-ENROLLMENT GUIDELINES ......................................................................................................................... 69 STUDY PRODUCT ............................................................................................................................... 70 REGIMEN ...................................................................................................................................................
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