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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
History of Changes
  Purpose

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 Intervention Phase
HIV Infection
 Drug: lopinavir/ritonavir
Drug: lamivudine/zidovudine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Antiviral efficacy by HIV RNA [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 138
Study Start Date: August 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Kaletra Monotherapy: lopinavir/ritonavir
 Drug: lopinavir/ritonavir
400 mg lopinavir/ 100 mg ritonavir, BID
Other Names:
  • ABT-378
  • lopinavir/ritonavir
  • 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
  • lopinavir/ritonavir
  • Kaletra
Drug: lamivudine/zidovudine
300mg lamivudine/150mg zidovudine, BID
Other Name: lamivudine/zidovudine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234923

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gerard Goldfarb, Abbott France Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00234923     History of Changes
Other Study ID Numbers: FRAN-03-001, EUDRACT: 2004-816-24, MONARK
Study First Received: September 13, 2005
Last Updated: April 1, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Abbott:
HIV Infection
Kaletra
Lopinavir
Ritonavir
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Lamivudine
Lamivudine, zidovudine drug combination
Ritonavir
 Lopinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013