Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients (MONARK)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234923
First received: September 13, 2005
Last updated: April 1, 2008
Last verified: April 2008

September 13, 2005
April 1, 2008
August 2003
February 2007   (final data collection date for primary outcome measure)
Antiviral efficacy by HIV RNA [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00234923 on ClinicalTrials.gov Archive Site
  • Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients

The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
HIV Infection
  • Drug: lopinavir/ritonavir
    400 mg lopinavir/ 100 mg ritonavir, BID
    Other Names:
    • ABT-378
    • lopinavir/ritonavir
    • Kaletra
  • Drug: lamivudine/zidovudine
    300mg lamivudine/150mg zidovudine, BID
    Other Name: lamivudine/zidovudine
  • Active Comparator: 1
    Kaletra Monotherapy: lopinavir/ritonavir
    Intervention: Drug: lopinavir/ritonavir
  • Active Comparator: 2
    Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
    Interventions:
    • Drug: lopinavir/ritonavir
    • Drug: lamivudine/zidovudine
Ghosn J, Flandre P, Cohen-Codar I, Girard PM, Chaix ML, Raffi F, Dellamonica P, Ngovan P, Norton M, Delfraissy JF; MONARK Study Group. Long-term (96-week) follow-up of antiretroviral-naïve HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010 Feb;11(2):137-42. Epub 2009 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
Not Provided
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Antiretroviral naïve
  • HIV RNA <100,000 copies/mL
  • CD4 cell count >100 cells/mL at screening
  • with Karnofsky Score > 70
  • If female,

    • non-pregnant and
    • not breastfeeding
  • No AIDS opportunistic infection within 30 days of screening

Exclusion Criteria:

  • Subject with an HIV primo-infection status
  • Recent history of drug and/or alcohol abuse
  • History of psychiatric illness
  • If presence of the following mutations :

    • in the protease : one among 32,47,48,50,82,84,90
    • OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
    • in the reverse transcriptase : 215 or 184.
  • If abnormal laboratory results such as :

    • Hb<8 g/dl
    • Absolute neutrophil count<750 cells/µl
    • Platelet count<50 000/ml
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00234923
FRAN-03-001, EUDRACT: 2004-816-24, MONARK
No
Gerard Goldfarb, Abbott France Medical Director, Abbott
Abbott
Not Provided
Study Director: Global Medical Information Abbott
Abbott
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP