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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234923

Acronym

MONARK

Enrollment

138

Registered

2005-10-10

Start date

2003-08-31

Completion date

Unknown

Last updated

2008-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV Infection, Kaletra, Lopinavir, Ritonavir, Treatment Naive

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

Interventions

DRUGlopinavir/ritonavir

400 mg lopinavir/ 100 mg ritonavir, BID

DRUGlamivudine/zidovudine

300mg lamivudine/150mg zidovudine, BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Antiviral efficacy by HIV RNA	48 Weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026