A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.
Public ClinicalTrials.gov record NCT00000641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00000641
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Interventions
- Ciprofloxacin hydrochloride Drug
- Ethambutol hydrochloride Drug
- Amikacin sulfate Drug
- Azithromycin Drug
- Rifampin Drug
- Clofazimine Drug
Drug
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Nov 30, 1994
- Last update posted
- Nov 2, 2021
Ends 1994
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | — | — |
| Washington U CRS | St Louis | Missouri | — | — |
| NJ Med. School CRS | Newark | New Jersey | 07103 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | — | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 27599 | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | — | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 45267 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000641 live on ClinicalTrials.gov.