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CompletedNCT00234923MONARKUpdated Apr 3, 2008

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

A Phase 3 interventional study of lopinavir/ritonavir and lamivudine/zidovudine in HIV Infection, sponsored by Abbott. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-03.

Sponsored by Abbott · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • HIV Infection

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Keywords

  • HIV Infection
  • Kaletra
  • Lopinavir
  • Ritonavir
  • Treatment Naive
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 138 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
138 participants (actual)

Study arms

  • Active comparator
    1

    Kaletra Monotherapy: lopinavir/ritonavir

    Drug: lopinavir/ritonavir

  • Active comparator
    2

    Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine

    Drug: lopinavir/ritonavir · Drug: lamivudine/zidovudine

Interventions

  • Druglopinavir/ritonavir

    400 mg lopinavir/ 100 mg ritonavir, BID

    Also known as: ABT-378, Kaletra

  • Druglamivudine/zidovudine

    300mg lamivudine/150mg zidovudine, BID

06

What researchers measure

Primary outcomes

  1. Antiviral efficacy by HIV RNA

    Time frame: 48 Weeks

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Tran TA, Ghosn J, Avettand-Fenoel V, Hendel-Chavez H, de Goer de Herve MG, Cohen-Codar I, Rouzioux C, Delfraissy JF, Taoufik Y. Residual HIV-1 replication may impact immune recovery in patients on first-line lopinavir/ritonavir monotherapy. J Antimicrob Chemother. 2015 Sep;70(9):2627-31. doi: 10.1093/jac/dkv138. Epub 2015 May 28. PubMed 26023212 ↗
  • 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-naive HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010 Feb;11(2):137-42. doi: 10.1111/j.1468-1293.2009.00752.x. Epub 2009 Aug 13. PubMed 19682100 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00234923
Lead sponsor
Abbott
First posted
Oct 10, 2005
Start date
Aug 2003
Primary completion
Feb 2007
Last update
Apr 3, 2008

Study contacts

Global Medical Information
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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