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

NCT ID: NCT01153269

Last Updated: 2011-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus-Infection

Keywords

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Human Immunodeficiency Virus Co-infection with Hepatitis B or Hepatitis C Tolerability Effectiveness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-infected patients with hepatitis co-infection

HIV-infected patients with co-infections of Hepatitis B or Hepatitis C

Lopinavir/Ritonavir (Kaletra)

Intervention Type DRUG

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Interventions

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Lopinavir/Ritonavir (Kaletra)

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Simianer, MD

Role: STUDY_DIRECTOR

Abbott Germany, Medical Department

Locations

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Site Reference ID/Investigator# 27575

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27592

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27588

Dortmund, , Germany

Site Status

Site Reference ID/Investigator# 27583

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 27587

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 27607

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 5355

Krefeld, , Germany

Site Status

Site Reference ID/Investigator# 27604

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KAL 1 HO

Identifier Type: -

Identifier Source: org_study_id