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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Abbott

Gilead Sciences

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )

ClinicalTrials.gov Identifier:

NCT00946595

First received: July 24, 2009

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 24, 2009
Last Updated Date	February 12, 2013
Start Date ^ICMJE	November 2009
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2009)	Proportion of patients without treatment failure at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00946595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2009)	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 ] [ Designated as safety issue: Yes ] Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] Evolution of CD4 cell count between Week 0 and Week 96 [ Time Frame: Between Week 0 and Week 96 ] [ Designated as safety issue: No ] Evaluation of treatment adherence [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: No ] Evaluation of treatment tolerance [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] Proportion of patients with loss of future drug options [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: No ] Evaluation of quality of life assessments [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: Yes ] Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients [ Time Frame: Between Week 0 and Week 96 ] [ Designated as safety issue: Yes ] Analysis of the determinants of the durability of the virological response [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: No ] Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant [ Time Frame: From Week 0 to Week 96 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: efavirenz/emtricitabin/tenofovir 1x600/200/245 mg per day (one tablet) between W0 et W98 Other Name: Atripla Drug: lopinavir/ritonavir 4 x 200/50 mg (4 tablets) once a day between W0 and W98 Other Name: Kaletra
Study Arm (s)	Active Comparator: efavirenz/emtricitabin/tenofovir Intervention: Drug: efavirenz/emtricitabin/tenofovir Experimental: lopinavir/ritonavir Intervention: Drug: lopinavir/ritonavir
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	420
Estimated Completion Date	July 2013
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00946595
Other Study ID Numbers ^ICMJE	2009-009776-13, ANRS 140 DREAM
Has Data Monitoring Committee	Yes
Responsible Party	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
Study Sponsor ^ICMJE	French National Agency for Research on AIDS and Viral Hepatitis
Collaborators ^ICMJE	Abbott Gilead Sciences
Investigators ^ICMJE	Not Provided
Information Provided By	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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