CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,413 enrolled
Drug / intervention
Tenofovir disoproxil +1 moredrug
Likely dose
Tenofovir disoproxil dailyAI-extracted
Key inclusion· 5
  • ✓Report injection drug use in the 6 months before screening
  • ✓HIV oral fluid test non-reactive at screening and pre-enrollment visits
  • ✓Possess a Thai National Identification Card
  • ✓Available and committed to DOT or monthly follow-up for at least 12 months
Key exclusion· 5
  • ✕History of significant renal, liver, or bone disease
  • ✕Positive urine pregnancy test or breastfeeding
  • ✕Breastfeeding
  • ✕Concurrent participation in any other HIV prevention trial or drug/vaccine safety trial (with exception for AIDSVAX B/E trial participants)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00119106
NCT00119106Phase 3Completed
CompareCT.gov

Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand

Centers for Disease Control and Prevention·interventional·Posted Jul 13, 2005·Updated Feb 10, 2021

In Brief

A Phase 3 clinical trial evaluating Tenofovir disoproxil and Placebo for HIV Infections. Completed, enrolled 2,413 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesThailand
CollaboratorsMinistry of Health, Thailand, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2005
Enrollment StartJun 1, 2005
Primary CompletionJul 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 21.0 years ago

Interventions

Tenofovir disoproxildrug

Antiretroviral

Placebodrug

Placebo