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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)

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ClinicalTrials.gov Identifier: NCT00234910
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 10, 2008
Sponsor:
Information provided by:

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Primary Completion Date : June 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 10, 2008
Last Verified: July 2008

Keywords provided by Abbott:
Lopinavir
Ritonavir
Kaletra
Tenofovir
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
Ritonavir
Lopinavir
Tenofovir
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