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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00002331 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
NOTE:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
Prior Medication:
Excluded:
Contacts and 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 | |
More Information
| 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 |
|
Mycobacterium avium-intracellular Infection Drug Therapy, Combination Ethambutol |
Clofazimine Acquired Immunodeficiency Syndrome Clarithromycin |
|
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 |