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Sponsored by: |
Pfizer |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002122 |
PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population.
SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.
Condition | Intervention | Phase |
Mycoses Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Azithromycin Drug: Rifabutin Drug: Fluconazole |
Phase III |
MedlinePlus related topics: | AIDS Fungal Infections Molds |
ChemIDplus related topics: | Rifabutin Azithromycin Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Efficacy Study |
Official Title: | A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients |
Estimated Enrollment: | 720 |
Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
ALL PATIENTS -
Concurrent Medication:
Excluded for fluconazole randomization:
United States, California | |||||
UCSD Treatment Ctr / Dept of Medicine and Pediatrics | |||||
San Diego, California, United States, 92103 | |||||
Santa Clara Valley Med Ctr | |||||
San Jose, California, United States, 951282699 | |||||
Harbor - UCLA Med Ctr | |||||
Torrance, California, United States, 90509 | |||||
UCI Med Ctr | |||||
Orange, California, United States, 92668 | |||||
Los Angeles County - USC Med Ctr | |||||
Los Angeles, California, United States, 90033 | |||||
United States, District of Columbia | |||||
Georgetown Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20007 | |||||
George Washington Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20037 | |||||
United States, Massachusetts | |||||
Univ of Massachusetts Med Ctr | |||||
Worcester, Massachusetts, United States, 01655 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Texas | |||||
Baylor College of Medicine | |||||
Houston, Texas, United States, 77005 | |||||
Univ of Texas Southwestern Med Ctr | |||||
Dallas, Texas, United States, 75235 | |||||
Houston Veterans Administration Med Ctr | |||||
Houston, Texas, United States, 77030 |
Pfizer |
Havlir DV, Mccutchan JA, Bozzette SA, Dunne M. A double-blind, randomized study of weekly azithromycin, daily rifabutin, and combination azithromycin and rifabutin for the prevention of Mycobactetum avium complex (MAC) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90
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Study ID Numbers: | 226A, 066-174 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002122 |
Health Authority: | United States: Food and Drug Administration |
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