Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Emtricitabine/tenofovir disoproxil fumarate; Emtricitabine/tenofovir disoproxil fumarate placebo; Tenofovir disoproxil fumarate; Tenofovir disoproxil fumarate placebo; Tenofovir 1% vaginal gel; Tenofovir placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg/300 mg tablet; placebo tablet; 300 mg tablet; placebo tablet; 1 gm/100 ml of 1% gel; placebo gel
Other intervention name(s): FTC/TDF; Truvada; FTC/TDF placebo; Truvada placebo; TDF; TDF placebo; TFV; 9-[2-(Phosphonomethoxy)propyl]adenine; TFV placebo
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Microbicide; HIV Seronegativity