Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Lopinavir
Ritonavir
Criteria
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 normal (ULN); Creatinine< 1.5 x ULN; Triglycerides
- Subjects have no evidence of grade III or IV adverse event or laboratory abnormality
(except for LFTs).

Exclusion Criteria:

No exclusion criteria.