Botswana Tenofovir Oral HIV Prophylaxis Trial

This study has been terminated.
(Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
Sponsor:
Collaborators:
Botswana Ministry of Health
Gilead Sciences
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00111150
First received: May 17, 2005
Last updated: March 16, 2007
Last verified: March 2007

May 17, 2005
March 16, 2007
September 2005
Not Provided
  • Adverse drug reactions in the tenofovir and placebo arms
  • HIV incidence in the tenofovir and placebo arms
Same as current
Complete list of historical versions of study NCT00111150 on ClinicalTrials.gov Archive Site
  • Changes in levels of unprotected sex during the trial
  • Adherence to medication
  • Antiretroviral (ARV) resistance patterns in seroconverters
  • Viral set point in seroconverters
Same as current
Not Provided
Not Provided
 
Botswana Tenofovir Oral HIV Prophylaxis Trial
Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infection
Drug: Tenofovir Disoproxil Fumarate 300 mg daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1200
March 2007
Not Provided

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
Both
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Botswana
 
NCT00111150
CDC-NCHSTP-4321, BOTUSA MB04
Yes
Not Provided
Centers for Disease Control and Prevention
  • Botswana Ministry of Health
  • Gilead Sciences
Study Chair: Dawn K Smith, MD, MS, MPH CDC and BOTUSA
Study Chair: Lynn A Paxton, MD, MPH Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP