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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234962
Recruitment Status : Terminated
First Posted : October 10, 2005
Last Update Posted : November 21, 2008
Information provided by:

September 13, 2005
October 10, 2005
November 21, 2008
August 2002
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Antiviral efficacy by HIV RNA
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Complete list of historical versions of study NCT00234962 on Archive Site
Treatment related discontinuations, predictors of adherence
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Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
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.
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infection
Drug: Lopinavir/Ritonavir
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2007
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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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Global Medical Information Abbott
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP