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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234910
First received: September 13, 2005
Last updated: July 9, 2008
Last verified: July 2008

September 13, 2005
July 9, 2008
January 2005
June 2007   (final data collection date for primary outcome measure)
  • 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 ]
Antiviral efficacy by HIV RNA
Complete list of historical versions of study NCT00234910 on ClinicalTrials.gov Archive Site
Adherence and quality of life [ Time Frame: 72 wks ] [ Designated as safety issue: No ]
Adherence and quality of life
Not Provided
Not Provided
 
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: Tenofovir DF
    TDF 300mg QD for 72 wks
    Other Name: Tenofovir DF
  • Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
    LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
    Other Names:
    • ABT-378
    • Kaletra
    • lopinavir/ritonavir
  • Experimental: A
    2 drug arm
    Interventions:
    • Drug: Tenofovir DF
    • Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
  • Active Comparator: B
    3 drug arm, SOC
    Intervention: Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
June 2008
June 2007   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234910
ITAL-04-002, EUDRACT 2004-000786-35, KALEAD
No
Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott
Abbott
Not Provided
Study Director: Umberto di Luzio Paparatti, MD Abbott
Abbott
July 2008

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