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The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
NCT00002331 · View on ClinicalTrials.gov ↗
Study Summary
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
Conditions Studied
Interventions
- DRUG Clofazimine
- DRUG Clarithromycin
- DRUG Ethambutol hydrochloride
Study Locations (18)
California
- Kaiser Permanente Med Ctr — Los Angeles
- UCD Med Ctr — Sacramento
- Kaiser Permanente Med Ctr — San Francisco
- Santa Clara Valley Med Ctr — San Jose
Florida
- Dr Margaret Fischel — Miami
- Saint Joseph's Hosp / Infectious Disease Rsch Institute — Tampa
New York
- Beth Israel Med Ctr — New York
- Mount Sinai Med Ctr — New York
Texas
- Univ of Texas Southwestern Med Ctr of Dallas — Dallas
- Houston Veterans Administration Med Ctr — Houston
District of Columbia
- George Washington Univ Med Ctr — Washington D.C.
Illinois
- Rush Presbyterian - Saint Luke's Med Ctr — Chicago
Louisiana
- Tulane Univ Med School — New Orleans
Maryland
- Johns Hopkins Univ School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Start Date | 1994-01 |
| Est. Completion | 1995-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002331
The ClinicalTrials.gov registry entry for NCT00002331 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Abbott, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions — of which Clofazimine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00002331 reports 18 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00002331 about?
NCT00002331 is a clinical study titled "The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS". PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time req...
What is the current status of trial NCT00002331?
This trial is currently completed. It is a NA study. The study started on 1994-01. Estimated completion is 1995-03.
What conditions does trial NCT00002331 study?
This clinical trial studies the following conditions: HIV Infections, Mycobacterium Avium-intracellular Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00002331?
The interventions under investigation include: Clofazimine (DRUG), Clarithromycin (DRUG), Ethambutol hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00002331?
This trial is sponsored by Abbott, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00002331 being conducted?
This trial has 18 study locations across California, District of Columbia, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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