NCT00448669

Botswana TDF/FTC Oral HIV Prophylaxis Trial

Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,219 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

Detailed description

Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
DRUG	Placebo Oral Tablet

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-03-19
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

2 sites across 2 countries: United States, Botswana