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Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand

NCT00119106 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2413

Last updated 2021-02-10

Study results available
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Summary

The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in HIV associated risk behaviors, adherence to study drug, and, among IDU who become HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic characterization of infecting HIV viruses, and antiretroviral resistance will also be done.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir disoproxil

Antiretroviral

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Kachit Choopanya, MD · Bangkok Tenofovir Study Group

  • Michael T Martin, MD, MPH · Centers for Disease Control and Prevention

  • Lynn Paxton, MD · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2013-07-31
Completion
2014-10-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00119106 on ClinicalTrials.gov