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Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Valme University Hospital
Sponsor:
Collaborators:
Hospital Universitario Reina Sofia
Hospital Universitario Virgen de la Victoria
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Regional de Malaga
Hospital Torrecárdenas
Complejo Hospitalario Universitario de Huelva
Hospital Universitario Puerta del Mar
Hospital Universitario Virgen Macarena
Hospital La Línea
Complejo Hospitalario de Jaén
Hospital Universitario Puerto Real
Hospital Universitario de Canarias
Hospital Poniente
Hospital Universitario Central de Asturias
Hospital Álvaro Cunqueiro
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario de Gran Canaria
Information provided by (Responsible Party):
José A. Mira Escarti, Valme University Hospital
ClinicalTrials.gov Identifier:
NCT02057003
First received: January 6, 2014
Last updated: October 14, 2016
Last verified: October 2016
  Purpose

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients.

Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.


Condition Intervention
Hepatitis C, Chronic
Human Immunodeficiency Virus
Drug: DAA against HCV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Security and Efficacy of Triple Therapy Including Direct-Acting Antivirals Against Chronic Hepatitis C Infection In HIV-Coinfected Patients In Real-Life Conditions: The Prospective HEPAVIR Cohort.

Resource links provided by NLM:


Further study details as provided by Valme University Hospital:

Primary Outcome Measures:
  • Number of patients who achieve SVR to DAA-based therapy as measure of efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Achievement of SVR to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.

  • Number of patients who develop severe adverse events as measure of safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Development of severe adverse events related to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.


Secondary Outcome Measures:
  • Number of patients who achieve SVR to a BOC-based regimen as compared to numbers of patients who achieve SVR to a TVR-based regimen. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    In order to compare TVR- and BOC-based therapy, the numbers of patients who achieve SVR to DAA-based therapy will be analyzed.

  • Number of patients who reach undetectable HCV-RNA at week 4 of PI-based therapy as a measure of on-treatment response to therapy. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of patients who develop adverse events during a BOC-based regimen as compared to numbers of patients who develop adverse events during a TVR-based regimen. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    In order to compare TVR- and BOC-based therapy, the numbers of patients who develop adverse events during either treatment will be analyzed.

  • Number of patients who achieve SVR to an interferon-free regimen. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    The numbers of patients who achieve SVR to DAA-based therapy in absence of interferon will be analyzed.


Estimated Enrollment: 1000
Study Start Date: January 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DAA-based therapy against HCV
HIV/HCV-coinfected patients who start therapy against HCV including one or more DAA
Drug: DAA against HCV
Other Names:
  • telaprevir
  • boceprevir
  • simeprevir
  • sofosbuvir
  • daclatasvir
  • ombitasvir
  • paritaprevir
  • dasabuvir
  • ledipasvir
  • grazoprevir
  • elbasvir
  • velpatasvir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who consecutively attend the Unit of Infectious Diseases of the Study Group for Viral Hepatitis (HEPAVIR) of the Andalusian Society of Infectious Diseases (Sociedad Andaluza de Enfermedades Infecciosas, SAEI), Spain, will be considered for this study.
Criteria

Inclusion Criteria:

  • Older than 18 years
  • HIV infection determined by enzymeimmunoassay and confirmed by Western Blot
  • Naïve to treatment including a DAA
  • Initiation of triple therapy including a DAA
  • Written informed consent to participate in the study and to undergo genetic determinations

Exclusion Criteria:

  • Pregnancy
  • Any contraindication for the administration of peg-IFN, RBV or the respective DAA
  • Patients who are not able to provide informed consent to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057003

Contacts
Contact: Karin Neukam, PhD 0034955015799 karin.neukam@gmail.com

Locations
Spain
Valme University Hospital Recruiting
Seville, Spain, 41014
Contact: Karin Neukam, PhD    0034955015799    karin.neukam@gmail.com   
Contact: Juan A Pineda, MD    0034955015684    japineda@telefonica.net   
Sponsors and Collaborators
Valme University Hospital
Hospital Universitario Reina Sofia
Hospital Universitario Virgen de la Victoria
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Regional de Malaga
Hospital Torrecárdenas
Complejo Hospitalario Universitario de Huelva
Hospital Universitario Puerta del Mar
Hospital Universitario Virgen Macarena
Hospital La Línea
Complejo Hospitalario de Jaén
Hospital Universitario Puerto Real
Hospital Universitario de Canarias
Hospital Poniente
Hospital Universitario Central de Asturias
Hospital Álvaro Cunqueiro
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario de Gran Canaria
Investigators
Principal Investigator: Karin Neukam, PhD Valme University Hospital
  More Information

Publications:

Responsible Party: José A. Mira Escarti, MD, Valme University Hospital
ClinicalTrials.gov Identifier: NCT02057003     History of Changes
Other Study ID Numbers: HEPAVIR-DAA 
Study First Received: January 6, 2014
Last Updated: October 14, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Valme University Hospital:
HIV
hepatitis C virus
sustained virologic response
telaprevir
boceprevir
simeprevir
sofosbuvir
daclatasvir
paritaprevir
pegylated interferon
ribavirin
direct-acting antivirals
dasabuvir
ombitasvir
ledipasvir
velpatasvir
grazoprevir
elbasvir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Hepatitis, Chronic
Simeprevir
Ledipasvir
Sofosbuvir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016