Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

• Sponsor: Population Health Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05580666
• Collaborator: (none)
• Enrollment: 8,000
• Arms: 2
• Anticipated Duration (Months): 46.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Disease Progression	Drug: Azithromycin Oral Tablet; Drug: Placebo oral tablet	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blinded placebo-controlled randomized trialDouble blinded placebo-controlled randomized trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blinded placebo-controlled
• Primary Purpose: Treatment
• Official Title: Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Aug 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral Azithromycin 250 mg once daily Active Azithromycin tablet	Drug: Azithromycin Oral Tablet; Antimicrobial therapy
Placebo Comparator: Oral matching placebo, once daily Matching placebo tablet	Drug: Placebo oral tablet; Inert ingredients

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [24 weeks after randomization]

   All-cause mortality over the first 24 weeks after randomization

Secondary Outcome Measures

1. All-cause mortality [12 weeks after randomization]

   All-cause mortality over the first 12 weeks after randomization

2. Hospitalization [24 weeks after randomization]

   Hospitalization over the first 24 weeks after randomization

3. Composite of hospitalization or all-cause mortality [24 weeks after randomization]

   Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years

2. Documented HIV infection

3. CD4 count criteria:

1. CD4 count ≤ 100 cells/mm3 within past 30 days if on ART; or

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

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

1. 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:

1. Contraindications to azithromycin:

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

1. Personal or family history of QT-prolongation

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Population Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Population Health Research Institute
• ClinicalTrials.gov Identifier: NCT05580666
• Other Study ID Numbers: PHRI.REVIVE
• First Posted: Oct 14, 2022
• Last Update Posted: Oct 14, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Population Health Research Institute: Human immunodeficiency virus; Antiretroviral therapy; Azithromycin; Mortality
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Disease Progression; Azithromycin

Study Results

No Results Posted as of Oct 14, 2022