CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Fixed dose combination zidovudine/lamivudine/abacavirdrug
Likely dose
Fixed dose combination zidovudine/lamivudine/abacavir 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00851630
NCT00851630Phase 4Completed
CompareCT.gov

A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Reconstitution Syndrome Trial (THIRST)

Duke University·interventional·Posted Feb 26, 2009·Updated May 4, 2010

In Brief

A Phase 4 clinical trial evaluating Fixed dose combination zidovudine/lamivudine/abacavir for HIV and Tuberculosis. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-associated immune reconstitution inflammatory syndromes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Tuberculosis
CountriesTanzania
CollaboratorsKilimanjaro Christian Medical Centre, Tanzania, Kibongoto National Tuberculosis Hospital, Tanzania, GlaxoSmithKline

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2009
Enrollment StartJun 1, 2004
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.3 years ago

Interventions

Fixed dose combination zidovudine/lamivudine/abacavirdrug

All subjects will receive fixed dose combination zidovudine(300 mg) / lamivudine (150 mg) / abacavir (300 mg) by mouth twice daily. Medications will be provided as long as deemed beneficial by the site investigator and study subject for up to two years. Toxicity substitutions are allowed per protocol.