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

April 1, 2008 updated by: Abbott

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antiviral efficacy by HIV RNA
Time Frame: 48 Weeks
48 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks
To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety
Time Frame: 96 weeks
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRAN-03-001
  • EUDRACT: 2004-816-24
  • MONARK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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