Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Abbott; Gilead Sciences
• Treatments: Efavirenz; Lopinavir; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Confirmed HIV-1 infection

• Stable antiretroviral treatment over 6 months

• HIV-1 RNA < 50 cp/mL for at least 12 months

• Lymphocytes CD4+ > 200/mm3

• Lymphocytes CD4+ nadir > 100/mm3

• Absence of prior treatment failure (defined by two successive HIV-1 RNA ≥ 50 cp/mL under NNRTI or PI treatment)

• Absence of documentation of a mutation conferring NRTI or NNRTI resistance or a primary mutation in the protease gene

• Written informed consent

• Patient affiliated to a social security scheme

Exclusion Criteria:

• Woman of child bearing potential without efficient contraception

• Pregnant or breastfeeding woman

• HBV infection (HbS Ag+)

• HBC infection requiring specific treatment during the trial

• Liver cirrhosis Child-Pugh C

• HIV-1/HIV-2 Co-infection or isolated HIV-2 infection

• Ongoing interleukin or interferon treatment

• Co-administration of contraindicated treatments

• Hypersensibility to efavirenz or lopinavir/r

• Absolute neutrophil count < 750/mm3, hemoglobin < 8g/dL, platelets < 60.000/mm3, creatinine clearance < 50 mL/min, ASAT, ALAT, lipase, alkaline phosphatase or total bilirubin > 3 ULN, CD4 nadir < 100/mm3.

• Participation in another clinical trial interfering with the study drug assignment in DREAM

• Subject under legal guardianship or incapacitation