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NCT00001033 · ClinicalTrials.gov registry record · Phase 3
The Treatment of Tuberculosis in HIV-Infected Patients
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 650
- Enrollment target
NCT00001033: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001033 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 650 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001033, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 650 participants
- Enrollment target
Study Summary
PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.
Interventions
- DRUG Pyrazinamide
- DRUG Isoniazid
- DRUG Pyridoxine hydrochloride
- DRUG Levofloxacin
- DRUG Ethambutol hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Est. Completion | 1997-07 |
| Phase | Phase 3 |
What the finished NCT00001033 record still lists
NCT00001033 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Pyrazinamide is the first listed.
NCT00001033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001033 about?
NCT00001033 is a clinical study titled "The Treatment of Tuberculosis in HIV-Infected Patients". PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resis...
What is the current status of trial NCT00001033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. Estimated completion is 1997-07.
What interventions are being tested in trial NCT00001033?
The interventions under investigation include: Pyrazinamide (DRUG), Isoniazid (DRUG), Pyridoxine hydrochloride (DRUG), Levofloxacin (DRUG), Ethambutol hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00001033?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001033's enrollment target sits among peer trials
650 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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