Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tenofovir disoproxil fumarate; Tenofovir gel
Intervention description: 300 mg tablet daily; 1 gm/100 ml of 1% gel vaginally daily
Intervention MeSH terms: Tenofovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 168.0
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) is an oral, FDA-approved,
      anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is
      to determine the adherence and acceptability to and blood levels of three daily regimens of
      tenofovir in both oral and gel form.
    

Eligibility criteria:

        Inclusion Criteria:

          -  General good health

          -  HIV-uninfected

          -  Normal menstrual cycle. More information can be found in the protocol.

          -  Creatinine clearance greater than 70 ml/min

          -  Sexually active. More information can be found in the protocol.

          -  Normal Pap smear result within 12 months prior to study entry

          -  Agrees to not participate in other investigational studies

          -  Willing to use effective forms of contraception. More information can be found in the
             protocol.

        Exclusion Criteria:

          -  Adverse reaction to either of the study products

          -  Adverse reaction to latex

          -  Currently sexually active with a partner with history of adverse reaction to latex

          -  More than three sexual partners in the month prior to screening

          -  Pathologic bone fracture not related to trauma

          -  Last pregnancy outcome within 90 days or less prior to enrollment

          -  Gynecologic or genital procedure within 90 days of study entry

          -  Enrollment in other investigational study within 30 days of study entry

          -  Nontherapeutic injection drug use within 12 months of screening

          -  Any social or medical condition that, in the opinion of the investigator, would
             interfere with the study

          -  Abnormal laboratory values

          -  Grade 2 or higher genital lesions, erythema, and/or edema or has any other abnormal
             physical or pelvic exam finding that, in the opinion of the investigator, would
             interfere with the study

          -  Kidney, reproductive, or urinary tract infection requiring treatment. More information
             on this criterion can be found in the protocol.

          -  Pregnant, breastfeeding, or intend to become pregnant

          -  Unwilling to comply with study participation requirements, including attendance at all
             scheduled study visits

          -  Per participant report, use of the following at enrollment, and/or anticipated use
             during the period of study participation - use of a diaphragm, vaginal ring, and/or
             spermicide for contraception, acyclovir or valacyclovir, post-exposure prophylaxis for
             HIV exposure, TDF/emtricitabine, non-study vaginal products