Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

NCT00729573 COMPLETED

The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	COMPLETED
Enrolment	518
Start date	2009-11
Completion	2013-05

Conditions

• HIV Infections

Interventions

• Emtricitabine/tenofovir disoproxil fumarate
• Emtricitabine/tenofovir disoproxil fumarate placebo
• Tenofovir disoproxil fumarate
• Tenofovir disoproxil fumarate placebo

Primary outcomes

• Changes in bone mineral density — Throughout study

Countries

Uganda, Zimbabwe