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

Abbott

Status and phase

Terminated

Phase 4

Conditions

HIV Infection

Treatments

Drug: Lopinavir/Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234962

PUER-01-001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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