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Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients (ANRS 140 DREAM)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
efavirenz/emtricitabin/tenofovir
lopinavir/ritonavir
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Undetectable, HIV infections, Monotherapy, Lopinavir/ritonavir, Protease inhibitor, Treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service des maladies infectieuses et tropicales Hopital Saint-Antoine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

efavirenz/emtricitabin/tenofovir

lopinavir/ritonavir

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients without treatment failure at Week 96

Secondary Outcome Measures

Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial
Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96
Proportion of patients with plasma HIV-1 RNA below 400 cp/mL at all time points during the trial
Evolution of CD4 cell count between Week 0 and Week 96
Evaluation of treatment adherence
Evaluation of treatment tolerance
Number and type of new resistance mutations in case of two successive plasma HIV-1 RNA ≥ 400 cp/mL
Proportion of patients with loss of future drug options
Evaluation of quality of life assessments
Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, without interference in daily functioning or functioning complaint between Week 0 and Week 96
Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, with interference in daily functioning or functioning complaint between Week 0 and Week 96
Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients
Analysis of the determinants of the durability of the virological response
Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant

Full Information

First Posted
July 24, 2009
Last Updated
June 23, 2014
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Abbott, Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00946595
Brief Title
Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients
Acronym
ANRS 140 DREAM
Official Title
A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Abbott, Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Undetectable, HIV infections, Monotherapy, Lopinavir/ritonavir, Protease inhibitor, Treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efavirenz/emtricitabin/tenofovir
Arm Type
Active Comparator
Arm Title
lopinavir/ritonavir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
efavirenz/emtricitabin/tenofovir
Other Intervention Name(s)
Atripla
Intervention Description
1x600/200/245 mg per day (one tablet) between W0 et W98
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir
Other Intervention Name(s)
Kaletra
Intervention Description
4 x 200/50 mg (4 tablets) once a day between W0 and W98
Primary Outcome Measure Information:
Title
Proportion of patients without treatment failure at Week 96
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial
Time Frame
From Week 0 to Week 96
Title
Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96
Time Frame
Week 96
Title
Proportion of patients with plasma HIV-1 RNA below 400 cp/mL at all time points during the trial
Time Frame
From Week 0 to Week 96
Title
Evolution of CD4 cell count between Week 0 and Week 96
Time Frame
Between Week 0 and Week 96
Title
Evaluation of treatment adherence
Time Frame
From Week 0 to Week 96
Title
Evaluation of treatment tolerance
Time Frame
From Week 0 to Week 96
Title
Number and type of new resistance mutations in case of two successive plasma HIV-1 RNA ≥ 400 cp/mL
Time Frame
From Week 0 to Week 96
Title
Proportion of patients with loss of future drug options
Time Frame
From Week 0 to Week 96
Title
Evaluation of quality of life assessments
Time Frame
From Week 0 to Week 96
Title
Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, without interference in daily functioning or functioning complaint between Week 0 and Week 96
Time Frame
Between Week 0 and Week 96
Title
Prevalence of acquired impairment in cognitive functioning, involving at least two ability domains, with interference in daily functioning or functioning complaint between Week 0 and Week 96
Time Frame
Between Week 0 and Week 96
Title
Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients
Time Frame
Between Week 0 and Week 96
Title
Analysis of the determinants of the durability of the virological response
Time Frame
From Week 0 to Week 96
Title
Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant
Time Frame
From Week 0 to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Service des maladies infectieuses et tropicales Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
72012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30968368
Citation
Garay OU, Nishimwe ML, Bousmah MA, Janah A, Girard PM, Chene G, Moinot L, Sagaon-Teyssier L, Meynard JL, Spire B, Boyer S. Cost-Effectiveness Analysis of Lopinavir/Ritonavir Monotherapy Versus Standard Combination Antiretroviral Therapy in HIV-1 Infected Patients with Viral Suppression in France (ANRS 140 DREAM). Pharmacoecon Open. 2019 Dec;3(4):505-515. doi: 10.1007/s41669-019-0130-7.
Results Reference
derived
PubMed Identifier
29767684
Citation
Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
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Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

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