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NCT00001058 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 246
- Enrollment target
NCT00001058 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 246 participants.
The verdict
NCT00001058, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 246 participants
- Enrollment target
Study Summary
To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
Interventions
- DRUG Ritonavir
- DRUG Rifabutin
- DRUG Clarithromycin
- DRUG Indinavir sulfate
- DRUG Ethambutol hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Est. Completion | 1999-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001058
The ClinicalTrials.gov registry entry for NCT00001058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 246 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 Ritonavir is the first listed.
NCT00001058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001058 about?
NCT00001058 is a clinical study titled "A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS". To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. It is believed that effective...
What is the current status of trial NCT00001058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. Estimated completion is 1999-01.
What interventions are being tested in trial NCT00001058?
The interventions under investigation include: Ritonavir (DRUG), Rifabutin (DRUG), Clarithromycin (DRUG), Indinavir sulfate (DRUG), Ethambutol hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00001058?
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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