Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

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

Detailed Description
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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.

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

Conditions
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HIV Disease Progression

Intervention / Treatment
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* Drug: Azithromycin Oral Tablet
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Documented HIV infection CD4 count criteria: i. CD4 count ≤ 100 cells/mm3 within past 30 days if on ART; 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 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: Contraindications to azithromycin: i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or ii. Personal or family history of QT-prolongation Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded placebo-controlled randomized trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Azithromycin 250 mg once daily<br>Active Azithromycin tablet | Drug: Azithromycin Oral Tablet<br>* Antimicrobial therapy<br>|
| Placebo Comparator: Oral matching placebo, once daily<br>Matching placebo tablet | Drug: Placebo oral tablet<br>* Inert ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality over the first 24 weeks after randomization | 24 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality over the first 12 weeks after randomization | 12 weeks after randomization | 
| Hospitalization | Hospitalization over the first 24 weeks after randomization | 24 weeks after randomization | 
| Composite of hospitalization or all-cause mortality | Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization | 24 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human immunodeficiency virus, Antiretroviral therapy, Azithromycin, Mortality