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NCT00023348 · ClinicalTrials.gov registry record · Phase 2
TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
A Phase 2 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00023348: Completed Phase 2 study, sponsored by Centers for Disease Control and Prevention.
NCT00023348 is a Phase 2 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00023348, a Phase 2 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
Primary Objectives: 1\) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. Secondary Objectives: 1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin. 2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. 3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy. 4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
Interventions
- DRUG Rifabutin
- DRUG Isoniazid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 1999-07 |
| Est. Completion | 2002-11 |
| Phase | Phase 2 |
What the finished NCT00023348 record still lists
NCT00023348 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Rifabutin is the first listed.
NCT00023348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00023348 about?
NCT00023348 is a clinical study titled "TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB". Primary Objectives: 1\) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. Secondary Objectives: 1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin. 2. To eva...
What is the current status of trial NCT00023348?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 1999-07. Estimated completion is 2002-11.
What interventions are being tested in trial NCT00023348?
The interventions under investigation include: Rifabutin (DRUG), Isoniazid (DRUG).
Who is sponsoring clinical trial NCT00023348?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00023348's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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