What is azithromycin studying for advanced HIV disease?

Azithromycin is being studied to see if it can help reduce the risk of death in adults with advanced HIV disease. This trial compares azithromycin taken daily to a placebo over 28 days. The Population Health Research Institute leads this effort to find new ways to improve outcomes for people with advanced HIV.

Who may be eligible for this advanced HIV disease clinical trial?

Adults aged 18 and older with documented HIV infection and a low CD4 count may be eligible. Participants must be able to start or restart HIV therapy soon and not have allergies to azithromycin or related antibiotics. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced HIV disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05580666

Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial

Led by Population Health Research Institute · Updated on 2025-09-03

8000

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether taking azithromycin as a preventive treatment can reduce the risk of death in adults with advanced HIV disease. This is a Phase 3, double-blind, placebo-controlled trial involving multiple centers. The study aims to understand if azithromycin prophylaxis can lower mortality compared to a placebo in this vulnerable population. Participants will be randomly assigned to receive either an oral azithromycin tablet or a matching placebo tablet once daily for 28 days. After this treatment period, they will be followed for 24 weeks to measure the main outcome of all-cause mortality. The total study participation will last 48 weeks to monitor both short-term and longer-term effects. During the study, participants will undergo assessments to track survival and hospitalizations at 12 and 24 weeks after starting the treatment. Researchers will closely monitor health outcomes and any hospital stays to evaluate the impact of azithromycin prophylaxis. Safety and adherence will be followed throughout the trial to ensure accurate measurement of results.

CONDITIONS

Brief Title

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Documented HIV infection
CD4 count 100 cells/mm3 or less within the past 4 weeks, or documented CD4 nadir 100 cells/mm3 or less with at least 6 months off antiretroviral therapy, or CD4 count 100 cells/mm3 or less if never treated with antiretroviral therapy
Ability to start, restart, or switch to an effective antiretroviral therapy within 4 weeks of enrollment

You will not qualify if you...

Allergy to azithromycin, erythromycin, or any macrolide antibiotic, or personal or family history of heart rhythm problems (QT prolongation)
Severe illness requiring immediate or ongoing hospitalization
Current use of off-label azithromycin prophylaxis or need for prolonged azithromycin or macrolide therapy longer than 7 days

Research Team

REVIVE Study Coordinator

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