Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Drug: Tenofovir DF; Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

• Registration Number: NCT00234910
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual 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: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2007-06
• Study Completion: 2008-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-09
• Last Update Posted: 2008-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• HIV positive
• >18 years of age
• HIV RNA> 400 copies/mL
• Any CD 4 cell count
• Antiretroviral naïve
• No acute illness

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tenofovir DF	2 drug arm
B	lopinavir/ritonavir with 2 Nucleoside RTIs	3 drug arm, SOC
A	lopinavir/ritonavir with 2 Nucleoside RTIs	2 drug arm

Primary Outcome Measures

Name	Time	Method
Antiviral efficacy by HIV RNA	72 wks
Incidence of adverse events	72 wks

Secondary Outcome Measures

Name	Time	Method
Adherence and quality of life	72 wks

Trial Locations

Locations (1)

Global Medical Information-Abbott; 🇺🇸 Abbott Park, Illinois, United States