Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia

This study has been terminated.
Sponsor:
Collaborators:
NCHADS - Ministry of Health of Cambodia
Kirby Institute
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00078182
First received: February 19, 2004
Last updated: August 8, 2008
Last verified: May 2005

February 19, 2004
August 8, 2008
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00078182 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia

Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.

Cambodia has one of the highest rates of HIV infection in Southeast Asia. At the end of 2002, HIV infection rates among Cambodian sex workers ranged from 14.8% to 28.8%. Tenofovir DF is a nucleotide reverse transcriptase inhibitor (NRTI) that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration (FDA) in October 2001. This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection. This is a collaborative study between the University of California, San Francisco, the University of New South Wales, and the Ministry of Health of Cambodia.

Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial. Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months. Participants will be evaluated for rates of HIV infection, adherence to the drug regimen, and changes in risk behaviors. All participants will be monitored throughout the trial for side effects and toxicity. Participants will be involved in the study for 14 months.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
Drug: Tenofovir DF
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
960
Not Provided
Not Provided

Inclusion Criteria

  • HIV uninfected
  • Report receiving money or gifts for vaginal or anal sexual intercourse in the year prior to study entry
  • Able to provide a street address of residence for themselves and two personal contacts who would know their whereabouts during the study period
  • Normal lab values within 14 days of study entry
  • Ability to understand spoken Khmer
  • Willing and able to provide written informed consent

Exclusion Criteria

  • Pregnant or breast-feeding
  • Previously diagnosed active or serious infections
  • Certain medications
  • Active alcohol or drug abuse that could interfer with the study
  • Previously diagnosed malignancies other than basal cell carcinoma
  • Any other condition that, in the opinion of the study officials, would preclude informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Cambodia
 
NCT00078182
1 U01 AI054241-01
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
  • NCHADS - Ministry of Health of Cambodia
  • Kirby Institute
Principal Investigator: Kimberly Shafer, MD
National Institute of Allergy and Infectious Diseases (NIAID)
May 2005

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