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

French National Agency for Research on AIDS and Viral Hepatitis420 enrolled

Overview

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).

Today, one of the challenges of HIV treatment is to overcome side effects and toxicity of long term antiretroviral therapy. A promising approach may be the simplification of treatment maintenance strategies, sparing certain antiretroviral drug classes. This is a two-year prospective phase II/III, multicenter randomized trial to evaluate the efficacy and tolerance of a lopinavir/ritonavir monotherapy as a maintenance regimen in HIV-infected adults. Enrolled patients must have had stable antiretroviral treatment and HIV-1 RNA below 50 cp/mL over the previous 12 months, and no prior treatment failure. Provided informed consent, 420 patients are randomized in a 1:1 ratio to two open-label treatment groups and receive either lopinavir/r 800/200mg per day or EFV/FTC/TDF 600/200/245 mg per day (fixed dose combination). The main objective is to assess treatment efficacy and tolerance after 2 years. In 80 patients, repeated DEXA measurements are performed during the trial in order to evaluate changes in bone mineral density and in body composition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

HIV Infections

Interventions

efavirenz/emtricitabin/tenofovirDRUG

1x600/200/245 mg per day (one tablet) between W0 et W98

lopinavir/ritonavirDRUG

4 x 200/50 mg (4 tablets) once a day between W0 and W98

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service des maladies infectieuses et tropicales Hopital Saint-Antoine

Paris, France

Outcomes

Primary Outcomes

Proportion of patients without treatment failure at Week 96

Time frame: Week 96