The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002331
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130315205536im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
Condition | Intervention |
---|---|
Mycobacterium Avium-Intracellular Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Clofazimine |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
Official Title: | A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS |
Resource links provided by NLM:
Further study details as provided by Abbott:
![](https://webarchive.library.unt.edu/web/20130315205536im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- History of HIV seropositivity.
- Disseminated MAC.
- Positive blood culture for MAC within 4 weeks prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- Ability to complete the study.
NOTE:
- Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
- Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
- Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
- Amikacin.
- Azithromycin.
- Capreomycin.
- Ciprofloxacin.
- Cycloserine.
- Ethionamide.
- Gentamicin.
- Kanamycin.
- Levofloxacin.
- Lomefloxacin.
- Ofloxacin.
- Rifampin.
- Rifabutin.
- Sparfloxacin.
- Streptomycin.
- Any other aminoglycosides, quinolones, and macrolides.
Patients with the following prior conditions are excluded:
History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
Prior Medication:
Excluded:
- Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
- Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
![](https://webarchive.library.unt.edu/web/20130315205536im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002331
Locations
United States, California | |
Kaiser Permanente Med Ctr | |
Los Angeles, California, United States, 90027 | |
UCD Med Ctr | |
Sacramento, California, United States, 95817 | |
Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Santa Clara Valley Med Ctr | |
San Jose, California, United States, 951282699 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Dr Margaret Fischel | |
Miami, Florida, United States, 33136 | |
Saint Joseph's Hosp / Infectious Disease Rsch Institute | |
Tampa, Florida, United States, 33614 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane Univ Med School | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Maryland | |
Johns Hopkins Univ School of Medicine | |
Baltimore, Maryland, United States, 21205 | |
United States, New York | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
Univ of North Carolina School of Medicine | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Pennsylvania | |
Dr Stephen Hauptman | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Vanderbilt Univ School of Medicine | |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
Houston Veterans Administration Med Ctr | |
Houston, Texas, United States, 77030 | |
Puerto Rico | |
Dr Javier Morales | |
Condado San Juan, Puerto Rico, 00907 |
Sponsors and Collaborators
Abbott
![](https://webarchive.library.unt.edu/web/20130315205536im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
ClinicalTrials.gov Identifier: | NCT00002331 History of Changes |
Other Study ID Numbers: | 214A, M93-069 |
Study First Received: | November 2, 1999 |
Last Updated: | February 19, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
Mycobacterium avium-intracellular Infection Drug Therapy, Combination Ethambutol |
Clofazimine Acquired Immunodeficiency Syndrome Clarithromycin |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Mycobacterium Infections, Atypical Clofazimine Ethambutol Clarithromycin Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on March 14, 2013