Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
ConditionHIV Disease Progression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
About this trial
A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Documented HIV infection
Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment
Disqualifiers
Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)
Off-label azithromycin prophylaxis or requirement for prolonged (> 7 days) azithromycin (or macrolide) therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Azithromycin Oral Tablet
DrugAntimicrobial therapy
Placebo oral tablet
DrugInert ingredients
Treatment groups
8,000 Participants
are divided into 2 treatment groupsGroup A: Oral Azithromycin 250 mg once dailyExperimental treatment 1 intervention
Group B: Oral matching placebo, once dailyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
All-cause mortality over the first 24 weeks after randomization
Time frame
24 weeks after randomizationSecondary outcomes
1
All-cause mortality
All-cause mortality over the first 12 weeks after randomization
Time frame
12 weeks after randomization2
Hospitalization
Hospitalization over the first 24 weeks after randomization
Time frame
24 weeks after randomization3
Composite of hospitalization or all-cause mortality
Composite of hospitalization or all-cause mortality over the first 24 weeks after randomization
Time frame
24 weeks after randomizationSponsors and contacts
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Source ClinicalTrials.gov