Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

July 30, 2015 updated by: Maimónides Biomedical Research Institute of Córdoba
This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.

Study Overview

Status

Unknown

Conditions

Detailed Description

In subjects co-infected with HIV, treatment of chronic HCV infection is particularly complex and requires considerable resources, including a very high cost is likely to increase with new antivirals.

A precise knowledge of the situation in each hospital would facilitate adequate provision of personal and material resources needed to adequately address this disease in each center and in the Community as a whole. Because all or the vast majority of patients coinfected HIV / HCV are staffed by specialists who are part of Hepavir group and / or Sociedad Andaluza de Enfermedades Infecciosas (SAEI), they are ideal for carrying out this study.

Study Type

Observational

Enrollment (Anticipated)

2800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The sample consists of all HIV-infected patients co-infected with an active chronic HCV.

Description

Inclusion Criteria:

  • Patients over 18 with HIV infection and active chronic hepatitis or SVR after treatment.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response
Time Frame: Up to twelve months
This variable will be collected as follow at each clinical visit: i) yes; ii) not valuable (patients still on treatment); or, iii) no (patients who has not initiated treatment in the corresponding visit).
Up to twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Investigators

  • Principal Investigator: Antonio Rivero Juárez, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEP-COI-1-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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