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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.
Information provided by:
Abbott Identifier:
First received: September 13, 2005
Last updated: July 9, 2008
Last verified: July 2008
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
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:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Antiviral efficacy by HIV RNA [ Time Frame: 72 wks ]
  • Incidence of adverse events [ Time Frame: 72 wks ]

Secondary Outcome Measures:
  • Adherence and quality of life [ Time Frame: 72 wks ]

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
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00234910

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

Responsible Party: Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott Identifier: NCT00234910     History of Changes
Other Study ID Numbers: ITAL-04-002
EUDRACT 2004-000786-35
Study First Received: September 13, 2005
Last Updated: July 9, 2008

Keywords provided by Abbott:
HIV infection
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017