Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 3:38 PM
Study NCT ID:
NCT05580666
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2022-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)
Sponsor:
Organization:
Raw JSON
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Total follow up duration will be 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented HIV infection\n3. CD4 count criteria:\n\n i. CD4 count ≤ 100 cells/mm3 within past 4 weeks; or\n\n ii. Documented CD4 nadir ≤ 100 cells/mm3 and complete interruption of ART for ≥ 6 months; or\n\n iii. Documented CD4 count ≤ 100 cells/mm3 if ART-naive\n4. Ability to initiate or re-initiate ART, or switch to an effective ART regimen if failing current therapy, within 4 weeks of enrolment\n\nExclusion Criteria:\n\n1. Contraindications to azithromycin:\n\n i. Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic; or\n\n ii. Personal or family history of QT-prolongation\n2. Severe illness requiring immediate or continued hospitalization (this will be in the judgment of site investigators)\n3. Off-label azithromycin prophylaxis or requirement for prolonged (\\> 7 days) azithromycin (or macrolide) therapy'}, 'identificationModule': {'nctId': 'NCT05580666', 'acronym': 'REVIVE', 'briefTitle': 'Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Reducing Mortality in Adults With Advanced HIV Disease, a Double Blinded Randomized Trial', 'orgStudyIdInfo': {'id': 'PHRI.REVIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Azithromycin 250 mg once daily', 'description': 'Active Azithromycin tablet', 'interventionNames': ['Drug: Azithromycin Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral matching placebo, once daily', 'description': 'Matching placebo tablet', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Azithromycin Oral Tablet', 'type': 'DRUG', 'description': 'Antimicrobial therapy', 'armGroupLabels': ['Oral Azithromycin 250 mg once daily']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Inert ingredients', 'armGroupLabels': ['Oral matching placebo, once daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abidjan', 'status': 'NOT_YET_RECRUITING', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Henri Chenal', 'role': 'CONTACT'}], 'facility': "Centre Intégré de Recherches Biocliniques d'Abidjan (CIRBA)", 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'status': 'NOT_YET_RECRUITING', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Albert Minga', 'role': 'CONTACT'}], 'facility': 'Centre médical de suivi des donneurs de sang (CMSDS)', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Abidjan', 'status': 'NOT_YET_RECRUITING', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Serge Koule', 'role': 'CONTACT'}], 'facility': 'Unité de Soins Ambulatoires et de conseils (USAC)', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Ādama', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Endashaw A Debela', 'role': 'CONTACT', 'email': 'endashawabebe21@gmail.com'}], 'facility': 'Adama Hospital Medical College', 'geoPoint': {'lat': 10.70587, 'lon': 39.55201}}, {'city': 'Āsela', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Gadisa D Ejeta', 'role': 'CONTACT', 'email': 'gadisa600@gmail.com'}], 'facility': 'Asella Referral and Teaching Hospital', 'geoPoint': {'lat': 7.95, 'lon': 39.13333}}, {'city': 'Jimma', 'status': 'RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Esayas K Gudina', 'role': 'CONTACT', 'email': 'esayas.gudina@ju.edu.et'}], 'facility': 'Jimma University Hospital', 'geoPoint': {'lat': 7.67344, 'lon': 36.83441}}, {'city': "Mek'ele", 'status': 'NOT_YET_RECRUITING', 'country': 'Ethiopia', 'contacts': [{'name': 'Hayelom Bayrau', 'role': 'CONTACT', 'email': 'hayelomk21@gmail.com'}], 'facility': 'Tigray health research institute (THRI)', 'geoPoint': {'lat': 13.49667, 'lon': 39.47528}}, {'city': 'Kumasi', 'status': 'NOT_YET_RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Yasmine Hardy', 'role': 'CONTACT'}], 'facility': 'Komfo Anokye Teaching Hospital', 'geoPoint': {'lat': 6.68848, 'lon': -1.62443}}, {'city': 'Kumasi', 'status': 'RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Daniel O Minkah', 'role': 'CONTACT', 'email': 'daminkah@yahoo.co.uk'}], 'facility': 'Kumasi South Hospital', 'geoPoint': {'lat': 6.68848, 'lon': -1.62443}}, {'city': 'Kumasi', 'status': 'RECRUITING', 'country': 'Ghana', 'contacts': [{'name': 'Sheila Bawa', 'role': 'CONTACT', 'email': 'aposuad@yahoo.com'}], 'facility': 'Suntreso Government Hospital', 'geoPoint': {'lat': 6.68848, 'lon': -1.62443}}, {'city': 'Lilongwe', 'status': 'NOT_YET_RECRUITING', 'country': 'Malawi', 'contacts': [{'name': 'Cecilia Kanyama', 'role': 'CONTACT'}], 'facility': 'Lilongwe Medical Relief Fund/UNC Project', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'Maputo', 'status': 'NOT_YET_RECRUITING', 'country': 'Mozambique', 'contacts': [{'name': 'Albertino Damasceno', 'role': 'CONTACT'}], 'facility': 'Faculty of Medicine, Eduardo Mondlane University', 'geoPoint': {'lat': -25.96553, 'lon': 32.58322}}, {'city': 'Abuja', 'status': 'NOT_YET_RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Vivian Kwaghe', 'role': 'CONTACT'}], 'facility': 'University of Abuja Teaching Hospital', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'city': 'Calabar', 'status': 'NOT_YET_RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Bassey Ekeng', 'role': 'CONTACT'}], 'facility': 'University of Calabar Teaching Hospital', 'geoPoint': {'lat': 4.95893, 'lon': 8.32695}}, {'city': 'Enugu', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Uchechukwu Unigwe', 'role': 'CONTACT'}], 'facility': 'University of Nigeria Teaching Hospital', 'geoPoint': {'lat': 6.44132, 'lon': 7.49883}}, {'city': 'Ibadan', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Olukemi Adekanmbi', 'role': 'CONTACT'}], 'facility': 'University College Hospital', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}, {'city': 'Jos', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Nigeria', 'facility': 'Jos University Teaching Hospital', 'geoPoint': {'lat': 9.92849, 'lon': 8.89212}}, {'city': 'Kano', 'status': 'NOT_YET_RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Garba Iliyasu', 'role': 'CONTACT'}], 'facility': 'Aminu Kano Teaching Hospital', 'geoPoint': {'lat': 12.00012, 'lon': 8.51672}}, {'city': 'Lago', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Lorhen Akase', 'role': 'CONTACT'}], 'facility': 'Lagos University Teaching Hospital', 'geoPoint': {'lat': 11.1836, 'lon': 10.4881}}, {'city': 'Sokoto', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Nigeria', 'facility': 'Usmanu Danfodiyo University Teaching Hos', 'geoPoint': {'lat': 13.06269, 'lon': 5.24322}}, {'city': 'Umuahia', 'status': 'NOT_YET_RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Chiedozie Maduka', 'role': 'CONTACT'}], 'facility': 'Federal Medical Center', 'geoPoint': {'lat': 5.52491, 'lon': 7.49461}}, {'city': 'Uyo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Nigeria', 'facility': 'University of Uyo Teaching Hospital', 'geoPoint': {'lat': 5.05127, 'lon': 7.9335}}, {'city': 'Yenagoa', 'status': 'NOT_YET_RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Dimie Ogoina', 'role': 'CONTACT'}], 'facility': 'Niger Delta University Teaching Hospital', 'geoPoint': {'lat': 4.92675, 'lon': 6.26764}}, {'city': 'Kigali', 'status': 'NOT_YET_RECRUITING', 'country': 'Rwanda', 'contacts': [{'name': 'Leopold Bitunguhari', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire de Kigali (CHUK)', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}, {'city': 'Freetown', 'status': 'RECRUITING', 'country': 'Sierra Leone', 'contacts': [{'name': 'Stephen Sevalie', 'role': 'CONTACT', 'email': 'stevesyllo@gmail.com'}], 'facility': '34 Military Hospital', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}, {'city': 'Freetown', 'status': 'RECRUITING', 'country': 'Sierra Leone', 'contacts': [{'name': 'Daniel Sesay', 'role': 'CONTACT'}], 'facility': 'College of Medicine and Allied Health Sciences, University of Sierra Leone', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}, {'city': 'Kenema', 'status': 'RECRUITING', 'country': 'Sierra Leone', 'contacts': [{'name': 'Abdulai T Jalloh', 'role': 'CONTACT', 'email': 'abdulaitjalloh@gmail.com'}], 'facility': 'Kenema Regional Hospital', 'geoPoint': {'lat': 7.87687, 'lon': -11.19025}}, {'city': 'Koidu', 'status': 'RECRUITING', 'country': 'Sierra Leone', 'contacts': [{'name': 'Mohamed I Marah', 'role': 'CONTACT', 'email': 'mmarah@pih.org'}], 'facility': 'Koidu Government Hospital', 'geoPoint': {'lat': 8.64387, 'lon': -10.9714}}, {'city': 'Makeni', 'status': 'RECRUITING', 'country': 'Sierra Leone', 'contacts': [{'name': 'Matilda Kamara', 'role': 'CONTACT', 'email': 'kamaramatilda9198@gmail.com'}], 'facility': 'Makeni Regional Hospital', 'geoPoint': {'lat': 8.88605, 'lon': -12.04417}}, {'city': 'Cape Town', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Chantel Schreuder', 'role': 'CONTACT'}], 'facility': 'Desmond Tutu Health Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Phiona Namale', 'role': 'CONTACT'}], 'facility': 'Groote Schuur Hospital -New main building, Infectious Disease Clinic G26', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Nicolene Le Roux', 'role': 'CONTACT'}], 'facility': 'New Somerset Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Leigh Wagner', 'role': 'CONTACT'}], 'facility': 'Ubuntu Clinic, Site B, Khayelitsha, Wellcome Centre', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Hlabisa', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Lucica D Thaver', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- Nkundusi Clinic', 'geoPoint': {'lat': -28.14519, 'lon': 31.87719}}, {'city': 'Hluhluwe', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Alungile N Fileyo', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- Hluhluwe Clinic', 'geoPoint': {'lat': -28.01895, 'lon': 32.26762}}, {'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Tom Boyles', 'role': 'CONTACT'}], 'facility': 'Wits Health Consortium (Pty) Ltd', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Klerksdorp', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'James C Innes', 'role': 'CONTACT'}], 'facility': 'The Aurum Institute', 'geoPoint': {'lat': -26.85213, 'lon': 26.66672}}, {'city': 'Mtubatuba', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Alungile N Fileyo', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- KwaMsane Clinic', 'geoPoint': {'lat': -28.41789, 'lon': 32.18483}}, {'city': 'Mtubatuba', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Sune Liebetrau', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- Mpukunyoni Clinic', 'geoPoint': {'lat': -28.41789, 'lon': 32.18483}}, {'city': 'Mtubatuba', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Lucica D Thaver', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- Mtubatuba Clinic', 'geoPoint': {'lat': -28.41789, 'lon': 32.18483}}, {'city': 'Mtubatuba', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Ngcebo Mhlongo', 'role': 'CONTACT'}], 'facility': 'Africa Health Research Institute (AHRI)- Somkhele Clinic', 'geoPoint': {'lat': -28.41789, 'lon': 32.18483}}, {'city': 'Port Elizabeth', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Denise Kyazze', 'role': 'CONTACT', 'email': 'denkyaz@gmail.com'}], 'facility': 'Livingstone hospital', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Veronica Ueckermann', 'role': 'CONTACT'}], 'facility': 'Steve Biko Academic Hospital, University of Pretoria', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Randburg', 'status': 'COMPLETED', 'country': 'South Africa', 'facility': 'Right to Care NPC, Esizayo Division', 'geoPoint': {'lat': -26.0941, 'lon': 28.00123}}, {'city': 'Rustenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'William L Brumskine', 'role': 'CONTACT'}], 'facility': 'The Aurum Institute', 'geoPoint': {'lat': -25.66756, 'lon': 27.24208}}, {'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Brenda C Kakayi', 'role': 'CONTACT', 'email': 'bkakayi@mujhu.org'}], 'facility': 'MUJHU', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Lydia Nakiyingi', 'role': 'CONTACT', 'email': 'lydiakiyingi@gmail.com'}], 'facility': 'SICRA Kampala', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lira', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Francis Kiweewa', 'role': 'CONTACT', 'email': 'fkiweewa@sicra.org'}], 'facility': 'SICRA Lira', 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}, {'city': 'Mbarara', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Keneth Kananura', 'role': 'CONTACT'}], 'facility': 'Mbarara Regional Referral hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}, {'city': 'Lusaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Zambia', 'contacts': [{'name': 'Masuzyo Chrwa', 'role': 'CONTACT'}], 'facility': 'The Center for Infectious Disease Research in Zambia (CIDRZ)- George Clinical Research Site', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Lusaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Zambia', 'contacts': [{'name': 'Ethel Kamuti', 'role': 'CONTACT'}], 'facility': 'The Center for Infectious Disease Research in Zambia (CIDRZ)- Matero Clinical Research Site', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Lusaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Zambia', 'contacts': [{'name': 'Katanekwa Njekwa', 'role': 'CONTACT'}], 'facility': 'The Center for Infectious Disease Research in Zambia (CIDRZ)-Chawama Clinical Research Site (CRS)', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'centralContacts': [{'name': 'REVIVE Study Coordinator', 'role': 'CONTACT', 'email': 'revive@phri.ca', 'phone': '905-297-3479'}], 'overallOfficials': [{'name': 'John Eikelboom, MBBS, MSc, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}, {'name': 'Sean Wasserman, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}