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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) NCHADS - Ministry of Health of Cambodia The National Centre in HIV Epidemiology and Clinical Research |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00078182 |
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 | Intervention | Phase |
HIV Infections HIV Seronegativity |
Drug: Tenofovir DF |
Phase II Phase III |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate |
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 |
Estimated 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Cambodia | |||||
NCAHDS | |||||
Phnom Penh, Cambodia |
National Institute of Allergy and Infectious Diseases (NIAID) |
NCHADS - Ministry of Health of Cambodia |
The National Centre in HIV Epidemiology and Clinical Research |
Principal Investigator: | Kimberly Shafer, MD |
Click here for more information on tenofovir DF. 
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Study ID Numbers: | 1 U01 AI054241-01 |
First Received: | February 19, 2004 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00078182 |
Health Authority: | United States: Food and Drug Administration |
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