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Clinical trialNCT00705679CompletedPhase 2Interventional

Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment5,029HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

South Africa
  • Soweto Mtn Crs

    Johannesburg, Gauteng, South Africa

  • Wits Reproductive Health and Hiv Institute Crs (wrhi Crs)

    Johannesburg, Gauteng, South Africa

  • Overport Crs

    Asherville, KwaZulu-Natal, South Africa

  • Chatsworth Crs

    Chatsworth, KwaZulu-Natal, South Africa

  • Ethekwini Crs

    Durban, KwaZulu-Natal, South Africa

  • Tongaat Crs

    Tongaat, KwaZulu-Natal, South Africa

  • Verulam Crs

    Verulam, KwaZulu-Natal, South Africa

  • Botha'S Hill Crs

    Westville, KwaZulu-Natal, South Africa

  • Isipingo Crs

    Westville, KwaZulu-Natal, South Africa

  • Umkomaas Crs

    eMkhomazi, KwaZulu-Natal, South Africa

  • Caprisa Aurum Crs

    Klerksdorp, South Africa

Uganda
  • Mu-Jhu Research Collaboration Crs

    Kampala, Uganda

Zimbabwe
  • Seke South Crs

    Chitungwiza, Zimbabwe

  • Zengeza Crs

    Chitungwiza, Zimbabwe

  • Spilhaus Crs

    Harare, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Emtricitabine →Tenofovir 1% vaginal gelTenofovir disoproxil →Tenofovir disoproxil fumarate placeboTenofovir placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2009
Primary completion
31 Aug 2012
Completion
31 Aug 2012
Last update posted
29 Oct 2021
Registered enrollment
5,029
Registry id
NCT00705679
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.