A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of March 20, 2025
Completed
Keywords
ClinConnect Summary
The need for MAC prophylaxis in advanced HIV disease is recognized. Prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4+ cell counts rebound in response to antiretroviral therapy.
In this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. Patients are switched to open-label azithromycin if they ha...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- You may be eligible for this study if you:
- • Are HIV-positive.
- • Have 2 CD4 counts over 100 cells/mm3 at least 30 days apart.
- • Have a history of CD4 counts under 50 cells/mm3.
- • Are at least 13 years old (need consent if under 18).
- • Are in reasonably good health.
- • Are expected to live for at least 6 months.
- • Are receiving anti-HIV medications at study entry.
- • Exclusion Criteria
- You will not be eligible for this study if you:
- • Have/had MAC disease.
- • Have been unable to take azithromycin in the past.
- • Are on any medications that act against MAC.
Trial Officials
Wafaa El-Sadr
Study Chair
William Burman
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Denver, Colorado, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Camden, New Jersey, United States
Newark, New Jersey, United States
Philadelphia, Pennsylvania, United States
Washington, District Of Columbia, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Albuquerque, New Mexico, United States
Detroit, Michigan, United States
New York, New York, United States
Richmond, Virginia, United States
San Francisco, California, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Related articles
Similar Trials