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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections HIV Seronegativity

Keywords

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Tenofovir DF

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Kimberly Shafer, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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NCAHDS

Phnom Penh, , Cambodia

Site Status

Countries

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Cambodia

Other Identifiers

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1U01AI054241-01

Identifier Type: NIH

Identifier Source: org_study_id

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