Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Microbicide Trials Network
• Treatments: Tenofovir

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