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Chemistry / Microbicides / Organofluorides / HIV/AIDS / Fixed dose combination / Tenofovir / Pre-exposure prophylaxis / Emtricitabine / Reverse-transcriptase inhibitor / Gilead Sciences / Medicine / Health


MTN-003 Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women Microbicide T
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Document Date: 2011-01-06 08:38:01


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City

Harare / /

Company

Network Laboratory / Community Working Group / CONRAD Gilead Sciences Inc. / AIDS ALT ART ARV AST AUC BMD BV / ABBREVIATIONS AND ACRONYMS 3TC ACASI AE / Opportunistic / /

Country

United States / /

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Event

FDA Phase / /

Facility

Human Development US National Institute of Mental Health US National Institutes of Health Grant / Laboratory Evaluations / US National Institute of Allergy / Laboratory Data Management System / Mantel-Haenszel Microbicide Trials Network National Institute of Allergy / Human Development National Institute of Mental Health / Infectious Diseases US National Institute of Child Health / Infectious Disease National Institute of Child Health / /

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IndustryTerm

Prevention of HIV / HIV Prevention / AIDS Prevention / energy / manufacturing / /

MedicalCondition

Infection/Reproductive Tract Infection / HIV / HBV / Glycosuria / acquired immunodeficiency syndrome / Div. of Allergy / I herpes / reverse transcriptase reproductive tract infection / human immunodeficiency virus HIV Prevention Trials Network hazard ratio herpes / sexually transmitted infection / HIV Infection / Proteinuria / equations hepatitis B / AIDS / HIV/AIDS / Infection / surface antigen hepatitis B / surface antibody hepatitis B / /

MedicalTreatment

antiretroviral therapy / /

Organization

South African MRC / National Institute of Health / World Health Organization / Food and Drug Administration / Regulatory Support Center / International Air Transport Association / Federal Trade Commission / MPH Protocol Co-chair Seattle STD/HIV Prevention Training Center Univ. of Washington / Data and Safety Monitoring Board / Data Center / office of Human Research Protections / Coordinating and Operations Center / United Nations / FDA / National Institute of Allergy / Division of AIDS / National Institute of Child Health / Institute of Mental Health US National Institutes of Health Grant / Statistical Center for HIV/AIDS Research / UNAIDS / Division of AIDS Dual / National Institute of Mental Health / /

Person

Zvavahera Mike Chirenje / Jeanne Marrazzo / ULN UNAIDS UTI VOICE WB / Yuki Sookrajh / Marwah Jenneker / Sharika Gappoo / Linda Zako / /

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Position

INVESTIGATOR / Dip HIV Man Site Investigator / PhD Site Investigator / Sci Site Investigator / drug Investigator of Record lopinavir Institutional Review Board / MBChB Site Investigator / MMed Sci Site Investigator / Co-chair / Medical Officer / adenine tenofovir diphosphate Pharmaceutical Product Development Pharmacist of Record pre-exposure prophylaxis Product Use End Visit Protocol Safety Review Team / /

Product

efavirenz / zidovudine / Emtricitabine/Tenofovir Disoproxil Fumarate Tablet / medroxyprogesterone acetate / Tenofovir Disoproxil Fumarate / Tenofovir Disoproxil Fumarate Tablet / nevirapine / lamivudine / MTN-003 Version 2.0 ii December 31 / Disoproxil Fumarate Tablet / stavudine / IL-2 / Women / MTN-003 2.0 ii December 31 / U01-AI068633 / MTN-003 / /

ProgrammingLanguage

EC / /

RadioStation

CORE / Fred / /

Region

South Africa / /

Technology

X-ray / 5-U01-AI068633-05 DAIDS Protocol / 1 1.1 Protocol / pharmacodynamics / Record pre-exposure prophylaxis Product Use End Visit Protocol / /

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