Botswana Tenofovir Oral HIV Prophylaxis Trial

NCT ID: NCT00111150

Last Updated: 2007-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-03-31

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Tenofovir Disoproxil Fumarate 300 mg daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Botswana Ministry of Health

OTHER_GOV

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Dawn K Smith, MD, MS, MPH

Role: STUDY_CHAIR

CDC and BOTUSA

Lynn A Paxton, MD, MPH

Role: STUDY_CHAIR

Centers for Disease Control and Prevention

Locations

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

BOTUSA HIV Prevention Research Unit

Francistown and Gaborone, , Botswana

Countries

United States; Botswana

Other Identifiers

BOTUSA MB04

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-4321

Identifier Type: -

Identifier Source: org_study_id