Phase 4
N=70
Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)
HIV · Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00851630 ↗Enrolled (actual)
70
Serious AEs
27.1%
Results posted
Jan 2010
Primary outcome: Primary: Number of Serious Adverse Events (SAEs) — 12; 7 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fixed dose combination zidovudine/lamivudine/abacavir (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events (SAEs) |
12; 7 | — |
| PRIMARY Tuberculosis-immune Reconstitution Inflammatory Syndrome Events |
0; 0 | — |
| SECONDARY Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml |
26; 31 | — |
| SECONDARY HIV RNA Level < 50 Copies/ml |
23; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- HIV Infection is documented by rapid HIV test or any licensed enzyme-linked immunosorbent assay (ELISA) test kit and confirmed with a different sample.
- Men or women admitted to Kibongoto or Marangu Hospitals with (a) recent (within 56 days) smear positive tuberculosis (pulmonary or extrapulmonary,) (b)total lymphocyte count =700/mm³, hemoglobin > 8 g/dL in women; >9 g/dL in men, serum creatinine = age 13.
- Ability and willingness of subject or legal guardian/representative to give written consent.
Exclusion Criteria
- Serious illness, other than tuberculosis, that requires systematic treatment and/or hospitalization, until either completion of therapy or clinical stability on therapy in the opinion of the investigator for at least 14 days prior to study entry. Oral and vaginal candidiasis, mucocutaneous herpes simples, and other illnesses which are minor in the opinion of the site investigator are exceptions
- Diagnosis of or suspicion of tuberculosis of the central nervous system.
- > 14 days of antituberculous therapy prior to screening.
- > 28 days of antituberculous therapy for active tuberculosis within the 6 months prior to screening.
- Recent past (within 28 days of study entry) or planned use of corticosteroids.
- Any condition that in the opinion of the investigator would compromise the subject's ability to participate in the study.
- Radiation or systemic chemotherapy within 45 days of entry.
- Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Allergy/sensitivity to any study drugs or their formulations.
Data sourced from ClinicalTrials.gov (NCT00851630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.