The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.
Condition or disease
Drug: Tenofovir Disoproxil Fumarate 300 mg daily
Phase 2Phase 3
Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be 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 will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be 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 will receive 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 will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 29 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
citizen of Botswana 18-29 years old
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 effective contraception
living within 1 hours travel of study clinic
pass comprehension test
willing and able to give informed 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