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THIRST: Trizivir in HIV/TB coinfection
NCT00851630Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2004
- Primary completion
- Sep 2007
- Countries
- 1
- Sponsor
- Duke University
- Modality
- Small Molecules
- Drugs
- abacavir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 4, randomised, open-label trial of abacavir in human immunodeficiency virus infection (HIV) (2 arms), sponsored by Duke University. Primary endpoints: Number of Serious Adverse Events at 104 weeks and Tuberculosis-immune Reconstitution Inflammatory Syndrome Events at 104 weeks. Started Jun 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Early Initiation
Trizivir started 2 weeks after TB therapy
Delayed Initiation
Trizivir started 8 weeks after TB therapy
03
Who it enrols
HIV-infected men and women >= 13 years old with recent smear-positive tuberculosis, CD4/lymphocyte count < 1200/mm3, and < 14 days of TB therapy. Must be ARV naive.
04
Endpoints
Primary
Number of Serious Adverse Events
Tuberculosis-immune Reconstitution Inflammatory Syndrome Events
Secondary
Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml
HIV RNA Level < 50 Copies/ml
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