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

Tracking Information

First Received Date ^ICMJE

February 19, 2004

Last Updated Date

August 8, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00078182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections
HIV Seronegativity

Intervention ^ICMJE

Drug: Tenofovir DF

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

960

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Cambodia

Administrative Information

NCT ID ^ICMJE

NCT00078182

Responsible Party

Study ID Numbers ^ICMJE

1 U01 AI054241-01

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

NCHADS - Ministry of Health of Cambodia
The National Centre in HIV Epidemiology and Clinical Research

Investigators ^ICMJE

Principal Investigator:

Kimberly Shafer, MD

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

May 2005

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