Clinical trial NCT00705679
Conditions: HIV Infections
Keywords: Microbicide HIV Seronegativity
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2009-08-01; Completion date: 2012-08-01
Enrollment: 5029 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and anti-HIV drugs (TDF, FTC/TDF), this study will measure the effectiveness and safety to and blood levels of the three interventions in three regimens given to HIV uninfected women.

The expected duration of participation for each participant ranges from a minimum of 12 months to a maximum of 38 months. Study participants will be randomly assigned into one of five study groups, each with a different regimen. Group 1 participants will take one TDF tablet daily and one FTC/TDF placebo tablet daily. Group 2 participants will take one TDF placebo tablet daily and one FTC/TDF tablet daily. Group 3 participants will take one TDF placebo tablet daily and one FTC/TDF placebo tablet daily. Group 4 participants will apply tenofovir 1% gel vaginally once daily. Group 5 participants will apply tenofovir 1% placebo gel vaginally once daily.

Study visits will occur every 28 days after enrollment. Medical history, a physical exam, behavioral and adherence assessment, urine and blood collection, and counseling will occur at all visits. Blood will also be collected and archived for future research at select visits. Pharmacokinetic studies will occur at some visits. A pap smear will occur at select visits. Some participants may have hair samples collected on an optional basis at study visits every 2 months.

Arms: arm 1: TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months arm 2: TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months arm 3: TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months arm 4: Application of tenofovir 1% vaginal gel once daily arm 5: Application of tenofovir placebo gel once daily
Interventions: intervention 1: Emtricitabine/tenofovir disoproxil fumarate intervention 2: Emtricitabine/tenofovir disoproxil fumarate placebo intervention 3: Tenofovir disoproxil fumarate intervention 4: Tenofovir disoproxil fumarate placebo intervention 5: Tenofovir 1% vaginal gel intervention 6: Tenofovir placebo
Intervention descriptions: intervention 1: 200 mg/300 mg tablet intervention 2: placebo tablet intervention 3: 300 mg tablet intervention 4: placebo tablet intervention 5: 1 gm/100 ml of 1% gel intervention 6: placebo gel

Protocol documents: