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

Phase 4

Completed

• Conditions: HIV Infection
• Interventions: Drug: Lopinavir/Ritonavir

• Registration Number: NCT00234975
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCV -	Lopinavir/Ritonavir	-
HCV +	Lopinavir/Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	Baseline, Week 4, Week 8, Week 16 and Week 24	Changes in liver functions enzyme.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures	Baseline, Week 4, Week 8, Week 16 and Week 24	Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load

Trial Locations

Locations (11)

Site Reference ID/Investigator# 4118; 🇵🇷 Bayamon, Puerto Rico

Site Reference ID/Investigator# 6298; 🇵🇷 Juana Diaz, Puerto Rico

Site Reference ID/Investigator# 4117; 🇵🇷 Ponce, Puerto Rico

Site Reference ID/Investigator# 4099; 🇵🇷 Ponce, Puerto Rico

Site Reference ID/Investigator# 4086; 🇵🇷 Rio Piedras, Puerto Rico

Site Reference ID/Investigator# 4119; 🇵🇷 Bayamon, Puerto Rico

Site Reference ID/Investigator# 6284; 🇵🇷 Las Piedras, Puerto Rico

Site Reference ID/Investigator# 4101; 🇵🇷 Mayaguez, Puerto Rico

Site Reference ID/Investigator# 4116; 🇵🇷 Playa de Ponce, Puerto Rico

Site Reference ID/Investigator# 4080; 🇵🇷 San Juan, Puerto Rico

Site Reference ID/Investigator# 4100; 🇵🇷 Santurce, Puerto Rico