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

ANRS 12372 MODERATO

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

2020-09-21

2025-02-05

2025-02-05

Active (not recruiting)

Early phase I

480

Inclusion Criteria: * HIV-1 infection * Age of legal majority * CD4 \> 200 cells/mm3 at pre-inclusion * Start first-line ART with non-nucleotide reverse transcriptase inhibitors including TDF+XTC+EFV for at least two years without a past history of virological failure, OR * Be on TDF+XTC+EFV for at least two years then DTG+XTC+TDF without a past history of virological failure, OR * Be on DTG+XTC+TDF (1st line regimen) for at least two years without a past history of virological failure * Absence of past history of virological failure (viral load above the threshold corresponding to the test used); two blips between 50 and 200 copies/ml are allowed. * At least 2 consecutive HIV-1 RNA \< 50 copies/ml within past 2 years, including HIV-1 RNA at pre-inclusion * Women with pregnancy potential are required to use an effective contraceptive method throughout the study follow up. * Signed informed consent Exclusion Criteria: * HIV-2 infection or HIV-1+2 infection * CD4 nadir \<100 cells/mm3 * Chronic Hepatitis B (HBs Ag positive in the pre-inclusion balance) * Ongoing active Tuberculosis * Ongoing severe opportunistic infection * Ongoing chemotherapy or immunotherapy * Grade \> 2 hemoglobin, neutrophil or platelet disorder * ALT≥ 3 times the upper limit of normal value * Creatinine clearance \< 50 ml/min (CKD-EPI) * Allergy to a trial drugs or drug component * Ongoing pregnancy or Refusal of contraception * Patient at risk of non-compliance * Ongoing treatment with a drug that should not be associated with one of the drugs used in the study (cf appendix E page 77) * Any symptoms or biological findings suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that may interfere with the interpretation of test results or jeopardize the health of patients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 480, 'type': 'ACTUAL'}}

2023-09-06