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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02511496
• Other study ID #: HEP-COI-1-2014
• Status: Not yet recruiting
• Phase: N/A
• First received: March 11, 2015
• Last updated: July 30, 2015
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: July 2015
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Blanca Quijano Ruiz, Pharmacist
• Phone: (+34) 677 90 65 67
• Email: blanca.quijano[@]imibic.org
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2800
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes
• Liver Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response	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	No