Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients
ANRS 140 DREAM
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
2 other identifiers
interventional
420
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Nov 2009
Typical duration for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 24, 2014
June 1, 2014
3.7 years
July 24, 2009
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients without treatment failure at Week 96
Week 96
Secondary Outcomes (14)
Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at all time points during the trial
From Week 0 to Week 96
Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96
Week 96
Proportion of patients with plasma HIV-1 RNA below 400 cp/mL at all time points during the trial
From Week 0 to Week 96
Evolution of CD4 cell count between Week 0 and Week 96
Between Week 0 and Week 96
Evaluation of treatment adherence
From Week 0 to Week 96
- +9 more secondary outcomes
Study Arms (2)
efavirenz/emtricitabin/tenofovir
ACTIVE COMPARATORlopinavir/ritonavir
EXPERIMENTALInterventions
1x600/200/245 mg per day (one tablet) between W0 et W98
4 x 200/50 mg (4 tablets) once a day between W0 and W98
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French National Agency for Research on AIDS and Viral Hepatitislead
- Abbottcollaborator
- Gilead Sciencescollaborator
Study Sites (1)
Service des maladies infectieuses et tropicales Hopital Saint-Antoine
Paris, 72012, France
Related Publications (2)
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.
PMID: 30968368DERIVEDLambert-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.
PMID: 29767684DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 27, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2013
Study Completion
January 1, 2014
Last Updated
June 24, 2014
Record last verified: 2014-06