A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylaxis for Disseminated Mycobacterium Avium Complex Disease and Bacterial Pneumonia Versus Deferred Prophylaxis in HIV-Infected Patients Who Experience Rebound in CD4 Cell Count Due to Active Antiretroviral Therapy

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03

850

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +

All Genders

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.

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