NCT00002122

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (planned)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mycoses
• Mycobacterium Avium-Intracellulare Infection
• HIV Infections

Interventions

Type	Name	Description
DRUG	Azithromycin
DRUG	Rifabutin
DRUG	Fluconazole

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

12 sites across 1 country: United States