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

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Lopinavir; Ritonavir

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:

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