Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Lopinavir/Ritonavir (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Abbott Official(s) and/or principal investigator(s): Global Medical Information, Study Director, Affiliation: Abbott
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Antiviral efficacy by HIV RNA
Secondary outcome: Treatment related discontinuations, predictors of adherence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
-
Locations and Contacts
Global Medical Information - Abbott, North Chicago, Illinois 60064, United States
Additional Information
Starting date: August 2002
Last updated: November 19, 2008
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