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

December 13, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Kirby Institute
NCHADS - Ministry of Health of Cambodia

Investigators

  • Principal Investigator: Kimberly Shafer, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 19, 2004

First Submitted That Met QC Criteria

February 19, 2004

First Posted (Estimate)

February 20, 2004

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01AI054241-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Tenofovir DF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe