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
NCT ID: NCT00002122
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
720 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Azithromycin
Rifabutin
Fluconazole
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Preventive therapy with isoniazid for M. tuberculosis.
* Maintenance therapy for CMV retinitis.
Patients must have:
* HIV infection or history of an AIDS-defining condition by CDC criteria.
* One documented CD4 count \< 100 cells/mm3 within 12 months prior to study entry.
* NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous).
* NO acute opportunistic infection.
* Life expectancy of more than 6 months.
* Consent of parent or guardian if less than legal age of consent.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
ALL PATIENTS -
* Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded.
* Serious hypersensitivity reactions to macrolides or rifampin.
* Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -
* Serious hypersensitivity reaction to fluconazole.
* Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).
* Positive baseline urine cryptococcal culture.
Concurrent Medication:
Excluded for fluconazole randomization:
* Maintenance therapy for deep fungal infections.
* Chronic therapy with ketoconazole or fluconazole.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCI Med Ctr
Orange, California, United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Countries
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References
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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
Other Identifiers
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066-174
Identifier Type: -
Identifier Source: secondary_id
226A
Identifier Type: -
Identifier Source: org_study_id