ANRS 12372 MODERATO Study

• Status: Recruiting
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

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 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), in terms of virological success at 96 weeks

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Mylan Laboratories
• Treatments: Atazanavir Sulfate; Dolutegravir; Efavirenz; Lamivudine; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• HIV-1 infection

• Age of legal majority

• CD4 > 200 cells/mm3 at pre-inclusion

• On stable first-line ART with TDF+XTC+EFV for at least 2 years.

• 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