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

This study is not yet open for patient recruitment.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
NCHADS - Ministry of Health of Cambodia
NCHECR - University of New South Wales, Australia
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition Treatment or Intervention Phase
HIV Infections
HIV Seronegativity
 Drug: tenofovir DF
Phase II
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia

Further Study Details: 

Expected Total Enrollment:  960

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

Exclusion Criteria


Location Information


Cambodia
      NCAHDS, Phnom Penh,  Cambodia
Soleak Sim, MD  12 82 06 92    ssim@online.com.kh 
Vonthanak, MD   research03@online.com.kh 

Study chairs or principal investigators

Kimberly Shafer, MD,  Principal Investigator

More Information

Click here for more information on tenofovir DF.

Study ID Numbers:  1 U01 AI054241-01
Record last reviewed:  February 2004
Record first received:  February 19, 2004
ClinicalTrials.gov Identifier:  NCT00078182
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20
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