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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234923
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : April 3, 2008
Information provided by:

September 13, 2005
October 10, 2005
April 3, 2008
August 2003
February 2007   (Final data collection date for primary outcome measure)
Antiviral efficacy by HIV RNA [ Time Frame: 48 Weeks ]
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Complete list of historical versions of study NCT00234923 on 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 ]
  • To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety [ Time Frame: 96 weeks ]
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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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
HIV Infection
  • Drug: lopinavir/ritonavir
    400 mg lopinavir/ 100 mg ritonavir, BID
    Other Names:
    • ABT-378
    • Kaletra
  • Drug: lamivudine/zidovudine
    300mg lamivudine/150mg zidovudine, BID
  • Active Comparator: 1
    Kaletra Monotherapy: lopinavir/ritonavir
    Intervention: Drug: lopinavir/ritonavir
  • Active Comparator: 2
    Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
    • Drug: lopinavir/ritonavir
    • Drug: lamivudine/zidovudine

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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EUDRACT: 2004-816-24
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Gerard Goldfarb, Abbott France Medical Director, Abbott
Not Provided
Study Director: Global Medical Information Abbott
April 2008

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