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Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT00234962
Recruitment Status : Terminated
First Posted : October 10, 2005
Last Update Posted : November 21, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Lopinavir/Ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.
Study Start Date : August 2002
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Antiviral efficacy by HIV RNA

Secondary Outcome Measures :
  1. Treatment related discontinuations, predictors of adherence

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

Inclusion Criteria:

  • Subject is documented HIV positive
  • Subject is greater than or equal to 18 years of age.
  • Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
  • Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
  • Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
  • Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin >8.0 g/dL; Absolute neutrophil count >750 cells/mL; Platelet count >20,000/mL; ALT or AST <3 x Upper Limit of Normal (ULN); Creatinine <1.5 x ULN; Triglycerides <750 mg/dL.
  • Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.

Exclusion Criteria:

Contacts and Locations
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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): NCT00234962


Locations
United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
More Information
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ClinicalTrials.gov Identifier: NCT00234962     History of Changes
Other Study ID Numbers: PUER-01-001
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

Keywords provided by Abbott:
HIV Infection
HAART
Lopinavir
 Ritonavir
Treatment Experienced
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
 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