HIV Infection
Conditions
Keywords
HIV incidence, HIV prevention
Brief summary
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.
Detailed description
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.
Interventions
DRUGTenofovir Disoproxil Fumarate 300 mg daily
Sponsors
Botswana Ministry of Health
Gilead Sciences
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* citizen of Botswana 18-29 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 effective contraception * living within 1 hours travel of study clinic * pass comprehension test * willing and able to give informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reactions in the tenofovir and placebo arms | — |
| HIV incidence in the tenofovir and placebo arms | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in levels of unprotected sex during the trial | — |
| Adherence to medication | — |
| Antiretroviral (ARV) resistance patterns in seroconverters | — |
| Viral set point in seroconverters | — |
Countries
Botswana, United States
Outcome results
None listed