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.

Abbott1 site in 1 country200 target enrollmentAugust 2002

ConditionsHIV Infection

DrugsLopinavir/Ritonavir

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: HIV Infection
Sponsor: Abbott
Enrollment: 200
Locations: 1
Primary Endpoint: Antiviral efficacy by HIV RNA
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

February 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility 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.