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Common TitleCAPRISA 004
Official Title Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
Phase Phase IIB
ClinicalTrials.gov NCT00441298
Categories PREPPregnancy/Women
Funding
Non-IndustryCentre for the AIDS Program of Research in South Africa (CAPRISA) and The United States Agency for I
References
  • Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168-74.
    [PubMed Abstract]
  • Abdool Karim SS, Abdool Karim Q, Kharsany AB, et al. Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection. N Engl J Med. 2015;373:530-9.
    [PubMed Abstract]
  • Karim QA, Kharsany AB, Frohlich JA, et al. Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial. Trials. 2011;12:67.
    [PubMed Abstract]
  • Matthews LT, Sibeko S, Mansoor LE, Yende-Zuma N, Bangsberg DR, Karim QA. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial. PLoS One. 2013;8:e56400.
    [PubMed Abstract]
  • Naranbhai V, Samsunder N, Sandler NG, et al. Neither microbial translocation nor TLR responsiveness are likely explanations for preexisting immune activation in women who subsequently acquired HIV in CAPRISA 004. J Acquir Immune Defic Syndr. 2013;63:294-8.
    [PubMed Abstract]

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