Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score

AbbVie

Status and phase

Completed

Phase 4

Conditions

HIV Infection

Treatments

Drug: Lopinavir/Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234975

PUER-02-003

Details and patient eligibility

About

The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented HIV positive.
At least 18 years of age.
Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
Subject Has a Karnofsky Score greater than or equal to 70.
Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
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 </=10 x upper limit of normal (ULN); Creatinine< 1.5 x ULN; Triglycerides </=750 mg/dL.
Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).