A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000947

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

850

Expected to finish

2000-07-01

Last updated by the study team

2021-11-03

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Consortium / Jon Kaiser Wellness Ctr — San Francisco, California, United States
• Community Consortium / UCSF — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• LSMUC / Lions Clinic — New Orleans, Louisiana, United States
• Catherine McAuley Health Ctr — Detroit, Michigan, United States
• Wayne State Univ - WSU/DMC / Univ Hlth Ctr — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research / New Mexico — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Grp / Harlem Hosp Ctr — New York, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Saint Joseph's Hosp — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium / Div of Infect Diseases — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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