Status:
COMPLETED
Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Abbott
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 :...
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 stra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00946595
Start Date
November 1 2009
End Date
January 1 2014
Last Update
June 24 2014
Active Locations (1)
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1
Service des maladies infectieuses et tropicales Hopital Saint-Antoine
Paris, France, 72012