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

HIV Infection Clinical Trial

— MONARK  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234923
• Other study ID #: FRAN-03-001
• Secondary ID: EUDRACT: 2004-81
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 1, 2008
• Start date: August 2003

Study information

• Verified date: April 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• lopinavir/ritonavir
400 mg lopinavir/ 100 mg ritonavir, BID
• lamivudine/zidovudine
300mg lamivudine/150mg zidovudine, BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiviral efficacy by HIV RNA		48 Weeks	No
Secondary	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	Yes
Secondary	To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety		96 weeks	Yes