Botswana Tenofovir Oral HIV Prophylaxis Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Tenofovir Disoproxil Fumarate 300 mg daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir Disoproxil Fumarate 300 mg daily|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions in the tenofovir and placebo arms |  |  | 
| HIV incidence in the tenofovir and placebo arms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV incidence, HIV prevention