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Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

RecruitingPhase 3

Sponsor: Population Health Research Institute

Conditions: HIV Disease Progression

Interventions: Azithromycin Oral Tablet, Placebo oral tablet

Countries: Côte d’Ivoire, Ethiopia, Ghana, Malawi, Mozambique, Nigeria, Rwanda, Sierra Leone

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (52)

Abidjan, Côte d’Ivoire
Abidjan, Côte d’Ivoire
Abidjan, Côte d’Ivoire
Ādama, Ethiopia
Āsela, Ethiopia
Jimma, Ethiopia
Mek'ele, Ethiopia
Kumasi, Ghana
Kumasi, Ghana
Kumasi, Ghana
Lilongwe, Malawi
Maputo, Mozambique
Abuja, Nigeria
Calabar, Nigeria
Enugu, Nigeria
Ibadan, Nigeria
Jos, Nigeria
Kano, Nigeria
Lago, Nigeria
Sokoto, Nigeria
Umuahia, Nigeria
Uyo, Nigeria
Yenagoa, Nigeria
Kigali, Rwanda
Freetown, Sierra Leone
Freetown, Sierra Leone
Kenema, Sierra Leone
Koidu, Sierra Leone
Makeni, Sierra Leone
Cape Town, South Africa
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