Status:
COMPLETED
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- No exclusion criteria.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00234975
Start Date
October 1 2002
End Date
January 1 2008
Last Update
January 3 2013
Active Locations (11)
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1
Site Reference ID/Investigator# 4118
Bayamón, Puerto Rico, 00960
2
Site Reference ID/Investigator# 4119
Bayamón, Puerto Rico, 00961
3
Site Reference ID/Investigator# 6298
Juana Díaz, Puerto Rico, 00795
4
Site Reference ID/Investigator# 6284
Las Piedras, Puerto Rico, 00771