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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Lopinavir/Ritonavir

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00960
    • Site Reference ID/Investigator# 4118
  • Bayamon, Puerto Rico, 00961
    • Site Reference ID/Investigator# 4119
  • Juana Diaz, Puerto Rico, 00795
    • Site Reference ID/Investigator# 6298
  • Las Piedras, Puerto Rico, 00771
    • Site Reference ID/Investigator# 6284
  • Mayaguez, Puerto Rico, 00680
    • Site Reference ID/Investigator# 4101
  • Playa de Ponce, Puerto Rico, 00731
    • Site Reference ID/Investigator# 4116
  • Ponce, Puerto Rico, 00717-1563
    • Site Reference ID/Investigator# 4117
  • Ponce, Puerto Rico, 00731
    • Site Reference ID/Investigator# 4099
  • Rio Piedras, Puerto Rico, 00926
    • Site Reference ID/Investigator# 4086
  • San Juan, Puerto Rico, 00908
    • Site Reference ID/Investigator# 4080
  • Santurce, Puerto Rico, 00909
    • Site Reference ID/Investigator# 4100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Carlos R Rivera-Vazquez, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: October 7, 2005
• First Posted (Estimate): October 10, 2005

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: January 2, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Ritonavir; Lopinavir; Phase 4
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: PUER-02-003