Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

• Status: Completed
• Trial end date: 2012-08-01
• 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) 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.

• 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: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

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