MedTrace Logo

ANRS 12372 MODERATO Study

NCT04022967 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2023-09-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mylan Laboratories

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Serge P. Eholié, MD, MSc, Pr · Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire

  • Roland Landman, MD · Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France

  • Xavier Anglaret, MD, PhD · Inserm 1219, Université de Bordeaux, France

  • Pierre-Marie Girard, MD, PhD · Infectious Diseases Department, University Hospital Saint Antoine, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2025-02-05
Completion
2025-02-05

Countries

  • Burkina Faso
  • Cameroon
  • Côte d’Ivoire

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022967 on ClinicalTrials.gov