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
Intervention: Emtricitabine/tenofovir disoproxil fumarate; Emtricitabine/tenofovir disoproxil fumarate placebo; Tenofovir disoproxil fumarate; Tenofovir disoproxil fumarate placebo; Tenofovir 1% vaginal gel; Tenofovir placebo
Intervention description: 200 mg/300 mg tablet; placebo tablet; 300 mg tablet; placebo tablet; 1 gm/100 ml of 1% gel; placebo gel
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5029.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Microbicide; HIV Seronegativity

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to provide adequate locator information

          -  Sexually active, defined as having vaginal intercourse at least once in the 3 months
             prior to screening

          -  Agree to not participate in other research studies involving drugs, medical devices,
             or vaginal products for duration of study.

          -  Agree to use effective method of contraception. More information on this criterion can
             be found in the protocol.

        Exclusion Criteria:

          -  HIV infected

          -  Known adverse reaction to any of the study products

          -  Known adverse reaction to latex

          -  Pathologic bone fracture not related to trauma

          -  Non-therapeutic injection drug use in the 12 months prior to screening

          -  Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment

          -  Last pregnancy outcome 42 days or less prior to enrollment

          -  Gynecologic or genital procedure 42 days or less prior to enrollment

          -  Participation in any other research study involving drugs, medical devices, or vaginal
             products 30 days or less prior to enrollment

          -  Currently using spermicide, interferon or interleukin therapy, or certain medications.
             More information on this criterion can be found in the protocol.

          -  Any significant uncontrolled active or chronic disease. More information on this
             criterion can be found in the protocol.

          -  Certain abnormal laboratory values. More information on this criterion can be found in
             the protocol.

          -  Intends to become pregnant in the 24 months after enrollment

          -  Plans to relocate or travel away from the study site for more than 8 consecutive weeks
             in the 24 months after enrollment

          -  Urinary tract infection

          -  Pelvic inflammatory disease, an STI, or reproductive tract infection requiring
             treatment

          -  Grade 2 or higher pelvic exam finding

          -  Any condition that, in the opinion of the investigator, would interfere with the study

          -  Pregnant or breastfeeding