Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients (ANRS 140 DREAM)
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ClinicalTrials.gov Identifier: NCT00946595 |
Recruitment Status
:
Completed
First Posted
: July 27, 2009
Last Update Posted
: June 24, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: efavirenz/emtricitabin/tenofovir Drug: lopinavir/ritonavir | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
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
|
- Proportion of patients without treatment failure at Week 96 [ Time Frame: Week 96 ]
- 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 ]
- Proportion of patients with plasma HIV-1 RNA below 50 cp/mL at Week 96 [ Time Frame: Week 96 ]
- 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 ]
- Evolution of CD4 cell count between Week 0 and Week 96 [ Time Frame: Between Week 0 and Week 96 ]
- Evaluation of treatment adherence [ Time Frame: From Week 0 to Week 96 ]
- Evaluation of treatment tolerance [ Time Frame: From Week 0 to Week 96 ]
- 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 ]
- Proportion of patients with loss of future drug options [ Time Frame: From Week 0 to Week 96 ]
- Evaluation of quality of life assessments [ Time Frame: From Week 0 to Week 96 ]
- 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 ]
- 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 ]
- Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients [ Time Frame: Between Week 0 and Week 96 ]
- Analysis of the determinants of the durability of the virological response [ Time Frame: From Week 0 to Week 96 ]
- Assessment of pharmacokinetic and pharmacodynamic parameters in both groups if relevant [ Time Frame: From Week 0 to Week 96 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946595
France | |
Service des maladies infectieuses et tropicales Hopital Saint-Antoine | |
Paris, France, 72012 |
Additional Information:
Responsible Party: | 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 |
First Posted: | July 27, 2009 Key Record Dates |
Last Update Posted: | June 24, 2014 |
Last Verified: | June 2014 |
Keywords provided by 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 ):
Undetectable HIV infections Monotherapy |
Lopinavir/ritonavir Protease inhibitor Treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Emtricitabine Efavirenz HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers |