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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 9, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antiviral efficacy by HIV RNA [ Time Frame: 72 wks ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 72 wks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Antiviral efficacy by HIV RNA

Change History

Complete list of historical versions of study NCT00234910 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adherence and quality of life [ Time Frame: 72 wks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adherence and quality of life

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: Tenofovir DF
Drug: lopinavir/ritonavir with 2 Nucleoside RTIs

Study Arms / Comparison Groups

Experimental: 2 drug arm
Active Comparator: 3 drug arm, SOC

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

152

Completion Date

June 2008

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00234910

Responsible Party

Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott

Study ID Numbers ^ICMJE

ITAL-04-002, EUDRACT 2004-000786-35, KALEAD

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Umberto di Luzio Paparatti, MD

Abbott

Information Provided By

Abbott

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP