Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00946595
• Date of registration: 24/07/2009
• Prospective Registration: Yes
• Primary sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Public title: Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients ANRS 140 DREAM
• Scientific 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
• Date of first enrolment: November 2009
• Target sample size: 420
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00946595
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: lopinavir/ritonavir

Drug: efavirenz/emtricitabin/tenofovir

Primary Outcome(s)

Proportion of patients without treatment failure at Week 96 [Time Frame: Week 96]

Secondary Outcome(s)

Evolution of densitometric parameters between Week 0 and Week 96 in 80 patients [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]

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]

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 50 cp/mL at all time points during the trial [Time Frame: From Week 0 to 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]

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]

Evaluation of treatment adherence [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]

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]

Evaluation of treatment tolerance [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]

Secondary ID(s)

ANRS 140 DREAM

2009-009776-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott

Gilead Sciences