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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)

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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infection
 Drug: Tenofovir DF
Drug: lopinavir/ritonavir with 2 Nucleoside RTIs
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 152
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
2 drug arm
 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
Active Comparator: B
3 drug arm, SOC
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234910

Locations
United States, Illinois
Global Medical Information-Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Umberto di Luzio Paparatti, MD Abbott
  More Information

No publications provided

Responsible Party: Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott
ClinicalTrials.gov Identifier: NCT00234910     History of Changes
Other Study ID Numbers: ITAL-04-002, EUDRACT 2004-000786-35, KALEAD
Study First Received: September 13, 2005
Last Updated: July 9, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Abbott:
Lopinavir
Ritonavir
Kaletra
 Tenofovir
HIV infection
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
 Tenofovir disoproxil
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013