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NCT00000641 · ClinicalTrials.gov registry record · Phase 2
A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT00000641 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 90 participants.
The verdict
NCT00000641, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. \[Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.\] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
Interventions
- DRUG Azithromycin
- DRUG Rifampin
- DRUG Ethambutol hydrochloride
- DRUG Ciprofloxacin hydrochloride
- DRUG Amikacin sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Est. Completion | 1994-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000641
The ClinicalTrials.gov registry entry for NCT00000641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 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 Azithromycin is the first listed.
NCT00000641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000641 about?
NCT00000641 is a clinical study titled "A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.". To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. \[Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or cl...
What is the current status of trial NCT00000641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. Estimated completion is 1994-12.
What interventions are being tested in trial NCT00000641?
The interventions under investigation include: Azithromycin (DRUG), Rifampin (DRUG), Ethambutol hydrochloride (DRUG), Ciprofloxacin hydrochloride (DRUG), Amikacin sulfate (DRUG).
Who is sponsoring clinical trial NCT00000641?
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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