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| Sponsored by: |
Abbott |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| 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-Intracellulare Infection HIV Infections |
Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Clofazimine |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Ethambutol hydrochloride Ethambutol Clarithromycin Clofazimine |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| 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 | |||||
| UCD Med Ctr | |||||
| Sacramento, California, United States, 95817 | |||||
| Santa Clara Valley Med Ctr | |||||
| San Jose, California, United States, 951282699 | |||||
| Kaiser Permanente Med Ctr | |||||
| Los Angeles, California, United States, 90027 | |||||
| Kaiser Permanente Med Ctr | |||||
| San Francisco, California, United States, 94115 | |||||
| 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 | |||||
| Houston Veterans Administration Med Ctr | |||||
| Houston, Texas, United States, 77030 | |||||
| Univ of Texas Southwestern Med Ctr of Dallas | |||||
| Dallas, Texas, United States, 75235 | |||||
| Puerto Rico | |||||
| Dr Javier Morales | |||||
| Condado San Juan, Puerto Rico, 00907 | |||||
| Abbott |
More Information
| Study ID Numbers: | 214A, M93-069 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002331 |
| Health Authority: | United States: Food and Drug Administration |
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