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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Lopinavir/Ritonavir


Participation Criteria
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Eligibility Criteria
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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). Exclusion Criteria: No exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HCV +<br> | Drug: Lopinavir/Ritonavir<br>* 400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator<br>* Other names: ABT-378, lopinavir/ritonavir, Kaletra;|
| Active Comparator: HCV -<br> | Drug: Lopinavir/Ritonavir<br>* 400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator<br>* Other names: ABT-378, lopinavir/ritonavir, Kaletra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure | Changes in liver functions enzyme. | Baseline, Week 4, Week 8, Week 16 and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures | Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load | Baseline, Week 4, Week 8, Week 16 and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lopinavir, Ritonavir, Phase 4, HIV