Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

Population Health Research Institute (PHRI)

Status and phase: Enrolling; Phase 3

Conditions: HIV Disease Progression

Treatments: Drug: Placebo oral tablet; Drug: Azithromycin Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05580666

PHRI.REVIVE

Details and patient eligibility

About

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

Full description

All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure. Total follow up duration will be 48 weeks.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years

2. Documented HIV infection

3. CD4 count criteria:

   i. CD4 count ≤ 100 cells/mm3 within past 4 weeks; or

   ii. Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or

   iii. Documented CD4 count ≤ 100 cells/mm3 if ART-naive

4. Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment

Exclusion criteria

1. Contraindications to azithromycin:

   i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or

   ii. Personal or family history of QT-prolongation

2. Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)

3. Off-label azithromycin prophylaxis or requirement for prolonged (> 7 days) azithromycin (or macrolide) therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

8,000 participants in 2 patient groups, including a placebo group

Oral Azithromycin 250 mg once daily

Experimental group

Description:

Active Azithromycin tablet

Treatment:

Drug: Azithromycin Oral Tablet

Oral matching placebo, once daily

Placebo Comparator group

Description:

Matching placebo tablet

Treatment:

Drug: Placebo oral tablet