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:
French National Agency for Research on AIDS and Viral Hepatitis
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: efavirenz/emtricitabin/tenofovir Drug: lopinavir/ritonavir |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Tenofovir
Efavirenz
Ritonavir
Lopinavir
Tenofovir Disoproxil Fumarate
Atripla
U.S. FDA Resources
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- Proportion of patients without treatment failure at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 420 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: efavirenz/emtricitabin/tenofovir |
Drug: efavirenz/emtricitabin/tenofovir
1x600/200/245 mg per day (one tablet) between W0 et W98
Other Name: Atripla
|
| Experimental: lopinavir/ritonavir |
Drug: lopinavir/ritonavir
4 x 200/50 mg (4 tablets) once a day between W0 and W98
Other Name: Kaletra
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| 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 History of Changes |
| Other Study ID Numbers: | 2009-009776-13, ANRS 140 DREAM |
| Study First Received: | July 24, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
Undetectable HIV infections Monotherapy |
Lopinavir/ritonavir Protease inhibitor Treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir Tenofovir |
Tenofovir disoproxil Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013