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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses; Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Azithromycin (Drug); Rifabutin (Drug); Fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
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
Study design: Treatment, Double-Blind, Efficacy Study
Detailed description:
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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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.
Locations and Contacts
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
UCI Med Ctr, Orange, California 92668, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Univ of Massachusetts Med Ctr, Worcester, Massachusetts 01655, United States
Univ of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Baylor College of Medicine, Houston, Texas 77005, United States
Univ of Texas Southwestern Med Ctr, Dallas, Texas 75235, United States
Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States
Additional Information
Related publications: 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
Last updated: June 23, 2005
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