Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A new approach to HIV prevention currently being studied includes the use of topical
      microbicides, substances that kill microbes. The purpose of this study is to determine the
      levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are
      expecting to deliver by cesarean.
    

Detailed description: 
      There is an urgent need for HIV prevention methods that women can initiate and control
      themselves. Topical microbicides represent one such method. Tenofovir 1% vaginal gel was
      chosen as a high priority microbicide candidate due to its activity in target cells for HIV
      infection of the vagina and cervix and the low frequency of local and systemic toxicity
      observed in a prior HIV Prevention Trials Network (HPTN) trial utilizing tenofovir 1% gel.
      The purpose of this study is to assess term pregnancy single-dose pharmacokinetics (PK) of
      tenofovir 1% gel in HIV uninfected pregnant women.

      The expected duration of participation for individually enrolled participants will depend on
      how early they enroll prior to the date of cesarean section, but may range from approximately
      3 to 6 weeks. An initial screening/enrollment visit will occur approximately 1 to 4 weeks
      prior to the participant's scheduled cesarean section, but no more than 4 weeks before the
      delivery date. A targeted physical exam, medical and medication history assessment, blood and
      urine collection, and a pelvic exam will occur at screening/enrollment. Tenofovir gel will be
      administered vaginally approximately 2 hours before the expected time of cesarean section. On
      the day of gel administration and cesarean delivery, a targeted physical exam, medical and
      medication history assessment, a pelvic exam, maternal blood tenofovir level measurement, and
      collection of placental and endometrial tissues, cord blood, and amniotic fluid will occur.

      After gel administration, PK measures will be taken at Hours 1, 2, 4, 6, 8, and 12; maternal
      blood tenofovir level measurement and a review of adverse events will also occur at these
      times. A 24-hour evaluation will occur between Hours 22 and 26. At this evaluation, a
      targeted physical exam, a review of adverse events, and tenofovir level measurement will
      occur. Each participant will be contacted between Days 10 and 18 to collect data on any
      adverse events they experience. In addition, an unscheduled visit may be necessary if an
      unresolved adverse event occurs on or after the 24-hour evaluation. If an unscheduled visit
      is required, the participant will undergo a targeted physical exam, medical and medication
      history assessment, blood and urine collection, a pelvic exam, and tenofovir level
      measurement.
    

Intervention name(s): Tenofovir 1% vaginal gel
Intervention type(s): Drug
Intervention description(s): topical gel containing 1% tenofovir
Intervention MeSH terms: Tenofovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microbicide; Pregnancy; HIV Seronegativity