REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE) - A randomised, double blinded, placebo-controlled, multicentre trial of Azithromycin prophylaxis for advanced HIV disease

REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202302799565020

Enrollment

8000

Registered

2023-02-09

Start date

2023-02-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Azithromycin

Placebo Comparator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years Documented HIV infection CD4 count criteria: CD4 count = 100 cells/mm3 within past 30 days if on ART; or Documented CD4 nadir = 100 cells/mm3 and complete interruption of ART for = 6 months; or Documented CD4 count = 100 cells/mm3 if ART-naive Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 2 weeks of enrolment

Exclusion criteria

Exclusion criteria: Contraindications to azithromycin: Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or Personal or family history of QT-prolongation Severe illness requiring immediate or continued hospitalisation* *This will be in the judgement of site investigators.

Design outcomes

Primary

Measure	Time frame
All-cause mortality at 24 weeks after randomisation	—

Secondary

Measure	Time frame
? All-cause mortality at 12 weeks ? Hospitalisation at 24 weeks ? Composite of hospitalisation and all-cause mortality at 24 weeks	—

Countries

South Africa

Contacts

Public ContactMeagan McMaster

Regulatory Manager

meagan.mcmaster@uct.ac.za+27216502602

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026