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

Completed · Phase 3

Conditions studied: Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002122

Run by

Pfizer

People needed

720

Last updated by the study team

2005-06-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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