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

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tenofovir DF

lopinavir/ritonavir with 2 Nucleoside RTIs

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

Global Medical Information-Abbott

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

2 drug arm

3 drug arm, SOC

Outcomes

Primary Outcome Measures

Antiviral efficacy by HIV RNA

Incidence of adverse events

Secondary Outcome Measures

Adherence and quality of life

Full Information

NCT ID

NCT00234910

First Posted

September 13, 2005

Last Updated

July 9, 2008

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00234910

Brief Title

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

Acronym

KALEAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, Treatment Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

2 drug arm

Arm Title

Arm Type

Active Comparator

Arm Description

3 drug arm, SOC

Intervention Type

Drug

Intervention Name(s)

Tenofovir DF

Intervention Description

TDF 300mg QD for 72 wks

Intervention Type

Drug

Intervention Name(s)

lopinavir/ritonavir with 2 Nucleoside RTIs

Other Intervention Name(s)

ABT-378, Kaletra, lopinavir/ritonavir

Intervention Description

LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks

Primary Outcome Measure Information:

Title

Antiviral efficacy by HIV RNA

Time Frame

72 wks

Title

Incidence of adverse events

Time Frame

72 wks

Secondary Outcome Measure Information:

Title

Adherence and quality of life

Time Frame

72 wks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umberto di Luzio Paparatti, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Global Medical Information-Abbott

City

Abbott Park

State/Province

Illinois

ZIP/Postal Code

60064

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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