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

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.

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

Inclusion Criteria:

• citizen of Botswana 18-39 years old
• sexually active
• HIV uninfected
• Hepatitis B and C uninfected
• Calculated creatinine clearance >= 60 mL/min
• hemoglobin >= 8 gm/dL
• ALT and AST <= 2x ULN
• total bilirubin <= 1.5 mg/dL
• total serum amylase <= 1.5x ULN
• Serum phosphorus >= 2.2 mg/dL
• willing to use hormonal contraception (females)
• living within 1 hours travel of study clinic
• pass comprehension test
• willing and able to give informed consent

Exclusion Criteria:

• 18-20 without parent/guardian consent
• history of significant renal or bone disease
• any chronic illness requiring ongoing prescription medication
• pregnant or breastfeeding
• planning to move away from site in the next year
• participating in another HIV prevention or vaccine safety trial
• any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements