Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women

Science

Volumn 329, Issue 5996, 2010, Pages 1168-1174

  Karim, Quarraisha Abdool ^a,b   Karim, Salim S Abdool ^a,b,c   Frohlich, Janet A ^a   Grobler, Anneke C ^a   Baxter, Cheryl ^a   Mansoor, Leila E ^a   Kharsany, Ayesha B M ^a   Sibeko, Sengeziwe ^a   Mlisana, Koleka P ^a   Omar, Zaheen ^a   Gengiah, Tanuja N ^a   Maarschalk, Silvia ^a   Arulappan, Natasha ^a   Mlotshwa, Mukelisiwe ^a   Morris, Lynn ^d   Taylor, Douglas ^e  

^a UNIVERSITY OF KWAZULU NATAL   (South Africa)

^b Department of Epidemiology Mailman School of Public Health Columbia University ^*  (United States)

^c UNIVERSITY OF KWAZULU NATAL   (South Africa)

^d NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

^e FAMILY HEALTH INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MICROBICIDE; PLACEBO; TENOFOVIR; ADENINE; AGENTS USED INTRAVAGINALLY; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; PHOSPHONIC ACID DERIVATIVE; TOPICAL ANTIINFECTIVE AGENT;

ANTIMICROBIAL ACTIVITY; CONDOM USE; HEALTH SERVICES; HUMAN IMMUNODEFICIENCY VIRUS; MONOGAMY; SEXUAL BEHAVIOR; WOMENS HEALTH;

ADULT; ANTIVIRAL RESISTANCE; ARTICLE; CLINICAL TRIAL; CONDOM; CONTRACEPTION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; INFECTION PREVENTION; MAJOR CLINICAL STUDY; PATIENT COMPLIANCE; PREGNANCY OUTCOME; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEXUAL BEHAVIOR; SOUTH AFRICA; VIRUS LOAD; ADOLESCENT; ANALOGS AND DERIVATIVES; DRUG EFFECTS; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; INTRAVAGINAL DRUG ADMINISTRATION; PHYSIOLOGY; PREGNANCY; RURAL POPULATION; STATISTICS AND NUMERICAL DATA; URBAN POPULATION; YOUNG ADULT;

KWAZULU-NATAL; SOUTH AFRICA;

ADENINE; ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; ANTI-HIV AGENTS; ANTI-INFECTIVE AGENTS, LOCAL; DOUBLE-BLIND METHOD; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INCIDENCE; ORGANOPHOSPHONATES; PATIENT COMPLIANCE; PREGNANCY; PREGNANCY OUTCOME; RURAL POPULATION; SEXUAL BEHAVIOR; SOUTH AFRICA; URBAN POPULATION; VAGINAL CREAMS, FOAMS, AND JELLIES; VIRAL LOAD; YOUNG ADULT;

EID: 77955930318     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1193748     Document Type: Article

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39. We pay tribute to the women who participated in this trial; their dedication and commitment made this study possible. We thank the Health Department of the City of Durban, the traditional leadership of Vulindlela, specifically N. Sondelani Zondi and N. Nsikayezwe Zondi, and members of the Community Advisory Boards at the Vulindlela and eThekwini Research Clinics. Q.A.K. is the co-principal investigator of the HIV Prevention Trials Network (HPTN) Prevention Leadership Group [NIH/National Institute of Allergy and Infectious Diseases (NIAID) U01 AI068619]. S.S.A.K. was the protocol chair of the HPTN 035 trial, which was supported by NIH (grants U01AI46749 and U01AI068633). The other authors have no financial conflicts of interest. By arrangement with Gilead Sciences and CONRAD, LIFElab - a biotechnology center of the South African Department of Science and Technology - acquired a voluntary nonexclusive royalty-free license for tenofovir gel for low-cost distribution in Africa. The CAPRISA 004 Tenofovir gel trial was supported by CAPRISA, the United States Agency for International Development (USAID), FHI (cooperative agreement GPO-A-00-05-00022-00 and contract 132119), and LIFElab. Support from CONRAD for the product manufacturing and packaging, as well as support from Gilead Sciences for the tenofovir used in the production of gel, is gratefully acknowledged. We thank NIH's Comprehensive International Program of Research on AIDS (CIPRA grant AI51794) and the Columbia University-Southern African Fogarty AIDS International Training and Research Programme (AITRP grant D43TW00231) for the research infrastructure and training that made this trial possible. The Trial Oversight Committee included Q.A.K., S.S.A.K. (CAPRISA), L. Claypool, J. Manning, J. Spieler (USAID), H. Gabelnick (CONRAD), B. Okole, C. Montague (LIFElab), J. Rooney (Gilead Sciences), W. Cates, L. Dorflinger, and D.T. (FHI). The study monitors were S. Combes, C. Katz, L. McNeil, and A. Troxler and the DSMB members were E. Bukusi, M. Chen (independent statistician), K. Dickson, C. Lombard, K. Mayer (chair), and S. Self.