Botswana Tenofovir Oral HIV Prophylaxis Trial

HIV Infection Clinical 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00111150
• Other study ID #: CDC-NCHSTP-4321
• Secondary ID: BOTUSA MB04
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 17, 2005
• Last updated: March 16, 2007
• Start date: September 2005
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentBotswana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections

Intervention

Drug:
• Tenofovir Disoproxil Fumarate 300 mg daily

Locations

Country	Name	City	State
Botswana	BOTUSA HIV Prevention Research Unit	Francistown and Gaborone
United States	Centers for Disease Control and Prevention	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Botswana Ministry of Health, Gilead Sciences

Countries where clinical trial is conducted

United States,  Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug reactions in the tenofovir and placebo arms
Primary	HIV incidence in the tenofovir and placebo arms
Secondary	Changes in levels of unprotected sex during the trial
Secondary	Adherence to medication
Secondary	Antiretroviral (ARV) resistance patterns in seroconverters
Secondary	Viral set point in seroconverters