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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-01-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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efavirenz/emtricitabin/tenofovir

Group Type ACTIVE_COMPARATOR

efavirenz/emtricitabin/tenofovir

Intervention Type DRUG

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

lopinavir/ritonavir

Group Type EXPERIMENTAL

lopinavir/ritonavir

Intervention Type DRUG

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

Interventions

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efavirenz/emtricitabin/tenofovir

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

Intervention Type DRUG

lopinavir/ritonavir

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

Intervention Type DRUG

Other Intervention Names

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Atripla Kaletra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No