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
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
HIV Infection Drug: lopinavir/ritonavir Drug: lamivudine/zidovudine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : August 2003
Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Kaletra Monotherapy: lopinavir/ritonavir
Drug: lopinavir/ritonavir
400 mg lopinavir/ 100 mg ritonavir, BID
Other Names:
  • ABT-378
  • Kaletra
Active Comparator: 2
Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
Drug: lopinavir/ritonavir
400 mg lopinavir/ 100 mg ritonavir, BID
Other Names:
  • ABT-378
  • Kaletra
Drug: lamivudine/zidovudine
300mg lamivudine/150mg zidovudine, BID

Primary Outcome Measures :
  1. Antiviral efficacy by HIV RNA [ Time Frame: 48 Weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety [ Time Frame: 96 weeks ]

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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:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00234923

Sponsors and Collaborators
Study Director: Global Medical Information Abbott

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gerard Goldfarb, Abbott France Medical Director, Abbott Identifier: NCT00234923     History of Changes
Other Study ID Numbers: FRAN-03-001
EUDRACT: 2004-816-24
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008

Keywords provided by Abbott:
HIV Infection
Treatment Naive

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
Lamivudine, zidovudine drug combination
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