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

Abbott

Status and phase: Completed; Phase 3

Conditions: HIV Infection

Treatments: Drug: lopinavir/ritonavir; Drug: lamivudine/zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234923

EUDRACT: 2004-816-24

FRAN-03-001

MONARK

Details and patient eligibility

About

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

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

138 participants in 2 patient groups

1

Active Comparator group

Description:

Kaletra Monotherapy: lopinavir/ritonavir

Treatment:

Drug: lopinavir/ritonavir

2

Active Comparator group

Description:

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

Treatment:

Drug: lamivudine/zidovudine

Drug: lopinavir/ritonavir