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
- Conditions
- MycosesMycobacterium Avium-Intracellulare InfectionHIV Infections
- Registration Number
- NCT00002122
- Lead Sponsor
- Pfizer
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 720
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
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, District of Columbia, United States
George Washington Univ Med Ctr
🇺🇸Washington, 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
Scroll for more (2 remaining)Los Angeles County - USC Med Ctr🇺🇸Los Angeles, California, United States