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OpenTrials
Completed

NCT Number: NCT00234923

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

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lopinavir/ritonavir

Drug

400 mg lopinavir/ 100 mg ritonavir, BID

Other names: ABT-378, Kaletra

Lamivudine/Zidovudine

Drug

300mg lamivudine/150mg zidovudine, BID

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Acronym: MONARK

Important dates

Study start
2003
Primary completion
2007
First posted
Oct 10, 2005
Registry last updated
Apr 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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