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
Launched by PFIZER · Aug 30, 2001
Trial Information
Current as of June 22, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
Houston, Texas, United States
Worcester, Massachusetts, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Torrance, California, United States
Dallas, Texas, United States
Orange, California, United States
San Diego, California, United States
San Jose, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials