Status:
TERMINATED
Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
Lead Sponsor:
Abbott
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00234962
Start Date
August 1 2002
End Date
February 1 2007
Last Update
November 21 2008
Active Locations (1)
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1
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064