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

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Drug: lopinavir/ritonavir; Drug: lamivudine/zidovudine

• Registration Number: NCT00234923
• Lead Sponsor: Abbott

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2007-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-01
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lopinavir/ritonavir	Kaletra Monotherapy: lopinavir/ritonavir
2	lamivudine/zidovudine	Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine
2	lopinavir/ritonavir	Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine

Primary Outcome Measures

Name	Time	Method
Antiviral efficacy by HIV RNA	48 Weeks

Secondary Outcome Measures

Name	Time	Method
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