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
2 other identifiers
interventional
720
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCI Med Ctr
Orange, California, 92668, United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, 92103, United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699, United States
Harbor - UCLA Med Ctr
Torrance, California, 90509, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77005, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04