A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
- Conditions
- Mycobacterium Avium-intracellulare InfectionHIV Infections
- Registration Number
- NCT00000947
- Brief Summary
This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease. This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy.
Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts. However, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease.
- Detailed Description
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 have an average CD4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days).
\[AS PER AMENDMENT 10/23/97: SUBSTUDY CPCRA 054: A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. Antibiotic susceptibility tests are then performed on isolates of S. pneumoniae.\] \[AS PER AMENDMENT 9/3/99: Participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until January 31, 2001. Data collection includes CD4 cell counts, viral RNA measurements, macrolide susceptibility in MAC isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Washington Reg AIDS Prog / Dept of Infect Dis
🇺🇸Washington, District of Columbia, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Richmond AIDS Consortium / Div of Infect Diseases
🇺🇸Richmond, Virginia, United States
Partners in Research / New Mexico
🇺🇸Albuquerque, New Mexico, United States
Catherine McAuley Health Ctr
🇺🇸Detroit, Michigan, United States
LSMUC / Lions Clinic
🇺🇸New Orleans, Louisiana, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
🇺🇸Detroit, Michigan, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Community Consortium / Jon Kaiser Wellness Ctr
🇺🇸San Francisco, California, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Saint Joseph's Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Community Consortium / UCSF
🇺🇸San Francisco, California, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
🇺🇸Camden, New Jersey, United States