Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

Completed

• Conditions: Human Immunodeficiency Virus-Infection
• Interventions: Drug: Lopinavir/Ritonavir (Kaletra)

• Registration Number: NCT01153269
• Lead Sponsor: Abbott

Brief Summary

The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-30
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-11
• Results First Submitted: 2011-11-16
• Results First Submitted QC: 2011-11-16
• Last Update Submitted: 2011-11-16
• Results First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients infected by HIV-1 and HBV or HCV
• Age ≥18 years
• Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Exclusion Criteria

• Contraindications as described in SmPC (summary of product characteristics) at the time of prescription

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-infected patients with hepatitis co-infection	Lopinavir/Ritonavir (Kaletra)	HIV-infected patients with co-infections of Hepatitis B or Hepatitis C

Primary Outcome Measures

Name	Time	Method
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	Week 144	The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Viral Load	Week 144	The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
CD4 Cell Count	Week 144	The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.

Trial Locations

Locations (8)

Site Reference ID/Investigator# 27587; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 27607; 🇩🇪 Hamburg, Germany

Site Reference ID/Investigator# 27575; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 27592; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 27588; 🇩🇪 Dortmund, Germany

Site Reference ID/Investigator# 27583; 🇩🇪 Frankfurt, Germany

Site Reference ID/Investigator# 27604; 🇩🇪 Muenster, Germany

Site Reference ID/Investigator# 5355; 🇩🇪 Krefeld, Germany