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COMPLETED
NCT04022967
PHASE3

ANRS 12372 MODERATO Study

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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

DRUG

dolutegravir

One daily tablet (50mg) during 96 weeks

DRUG

atazanavir boosted with ritonavir

One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks

DRUG

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

DRUG

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