Chronic Hepatitis CNCT02511496
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
An observational study of Chronic Hepatitis C and Human Immunodeficiency Virus (HIV), run by Maimónides Biomedical Research Institute of Córdoba.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Human Immunodeficiency Virus (HIV)
- How many people
- 2,800 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample consists of all HIV-infected patients co-infected with an active chronic HCV.
Who may be able to join
- Patients over 18 with HIV infection and active chronic hepatitis or SVR after treatment.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Medical subject headings
- Hepatitis C, Chronic, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Rivero Juárez, Principal investigator, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511496
- Sponsor's protocol ID
- HEP-COI-1-2014
- Status last verified
- Jul 2015
- First submitted
- 11 Mar 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rivero-Juarez A, Guijo-Rubio D, Tellez F, Palacios R, Merino D, Macias J, Fernandez JC, Gutierrez PA, Rivero A, Hervas-Martinez C. Using machine learning methods to determine a typology of patients with HIV-HCV infection to be treated with antivirals. PLoS One. 2020 Jan 10;15(1):e0227188. doi: 10.1371/journal.pone.0227188. eCollection 2020.
PubMed 31923277
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
- ClinicalTrials.gov ID
- NCT02511496
- Acronym / sponsor ID
- HEP-COI-1-2014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample consists of all HIV-infected patients co-infected with an active chronic HCV.
Key inclusion criteria (1 listed)
- Patients over 18 with HIV infection and active chronic hepatitis or SVR after treatment.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Derived from this study: PubMed 31923277Rivero-Juarez A, Guijo-Rubio D, Tellez F, Palacios R, Merino D, Macias J, Fernandez JC, Gutierrez PA, Rivero A, Hervas-Martinez C. Using machine learning methods to determine a typology of patients with HIV-HCV infection to be treated with antivirals. PLoS One. 2020 Jan 10;15(1):e0227188. doi: 10.1371/journal.pone.0227188. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Rivero Juárez principal investigator
Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C and Human Immunodeficiency Virus (HIV), run by Maimónides Biomedical Research Institute of Córdoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca Quijano Ruiz, Pharmacist ((+34) 677 90 65 67, blanca.quijano@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (time frame: Up to twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.