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

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234962
First received: September 13, 2005
Last updated: November 19, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
HIV Infection
 Drug: Lopinavir/Ritonavir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

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

Secondary Outcome Measures:
  • Treatment related discontinuations, predictors of adherence

Estimated Enrollment: 200
Study Start Date: August 2002
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00234962     History of Changes
Other Study ID Numbers: PUER-01-001
Study First Received: September 13, 2005
Last Updated: November 19, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013