Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
Phase 4
Terminated
- Conditions
- HIV Infection
- Registration Number
- NCT00234962
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Antiviral efficacy by HIV RNA
- Secondary Outcome Measures
Name Time Method Treatment related discontinuations, predictors of adherence
Trial Locations
- Locations (1)
Global Medical Information - Abbott
🇺🇸North Chicago, Illinois, United States