Botswana TDF/FTC Oral HIV Prophylaxis Trial (TDF2)
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV incidence, HIV prevention, Tenofovir, Emtricitabine, Botswana, HIV seronegativity
Eligibility Criteria
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
Sites / Locations
- Centers for Disease Control and Prevention
- BOTUSA HIV Prevention Research Unit
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
TDF-FTC,condoms,adh/risk counseling
Placebo,condoms,adh/risk counseling
Eligible participants were randomized to oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet. The ratio of randomization was 1:1. Participants randomized to the active arm received male and female condoms, risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Eligible participants were randomized to the placebo arm and received placebo oral tablets that were visually identical to the TDF-FTC tablet and taken once daily. The placebo tablets contained no active ingredients. The ratio of randomization was 1:1. Participants randomized to the placebo arm received male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.