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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001033
The ClinicalTrials.gov registry entry for NCT00001033 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pyrazinamide is the first listed.
NCT00001033 reports 0 study locations.
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.
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