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ANRS 12372 MODERATO Study
Sponsor: ANRS, Emerging Infectious Diseases
Summary
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso). HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks. The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks
Official title: Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) or Dolutegravir + Lamivudine + Tenofovir (DTG+3TC+TDF) in West and Central African HIV-1 Infected Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2020-11-17
Completion Date
2024-12-30
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
dolutegravir
One daily tablet (50mg) during 96 weeks
atazanavir boosted with ritonavir
One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks
tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
One daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks OR One daily tablet with dolutegravir 50 mg + lamivudine (300 mg) + tenofovir (300 mg) during 96 weeks
Lamivudine
One daily tablet (300mg) during 96 weeks
Locations (5)
Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou
Bobo-Dioulasso, Burkina Faso
Service de médecine interne, CHU Yalgado Ouédraogo
Ouagadougou, Burkina Faso
Service des Maladies Infectieuses, Hôpital du jour, Hôpital Central
Yaoundé, Cameroon
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan, Côte d’Ivoire
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de Treichville
Abidjan, Côte d’Ivoire