Clinical trial NCT00111150: Botswana Tenofovir Oral HIV Prophylaxis Trial
Official title: Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: HIV Infection
Keywords: HIV incidence
HIV prevention
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Botswana Ministry of Health
name: Gilead Sciences
First posted: 2005-05-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse drug reactions in the tenofovir and placebo arms
measure: HIV incidence in the tenofovir and placebo arms
Secondary outcomes:
measure: Changes in levels of unprotected sex during the trial
measure: Adherence to medication
measure: Antiretroviral (ARV) resistance patterns in seroconverters
measure: Viral set point in seroconverters
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: Francistown and Gaborone
country: Botswana
facility: BOTUSA HIV Prevention Research Unit
Study officials:
affiliation: CDC and BOTUSA
name: Dawn K Smith, MD, MS, MPH
role: STUDY_CHAIR
affiliation: Centers for Disease Control and Prevention
name: Lynn A Paxton, MD, MPH
role: STUDY_CHAIR
References: