Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected SubjectshEPAticNCT02196064
Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."
An observational study of Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial summary
To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects
- How many people
- 519 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jul 2015
- 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: A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
Who may be able to join
- ≥ 18 years old.
- Chronic HIV-1 infection, as diagnosed on the basis of the presence of serum HIV antibodies detected by EIA and western-blot.
- Chronic HCV infection as proven by detecting HCV antibodies in plasma, as well as detectable plasma HCV-RNA by PCR.
- To start a new ART regimen during the study period.
Who cannot join
- Subjects with hepatotoxic events in the 2 months previous to Eviplera® treatment.
- Acute infections or uncontrolled chronic infection in the two months previous to Eviplera® treatment.
- Concomitant use of any drug with potential drug-drug interaction with Eviplera®.
- Documented resistance to study drugs.
- Concomitant therapy including anti-HCV agents, cytotoxic chemotherapy or immunosuppressors during Eviplera® treatment.
- Subjects taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks before Eviplera® treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort." hEPAtic Study.
To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Read the detailed description
This is a retrospective analysis of the prospective multicenter, observational "HEPAVIR HEPATIC SAFETY Cohort" (NCT01908660), in which the hepatic safety of the three-drug combination TDF/FTC/RPV will be assessed. A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
The main objective is to evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Variables collected within in the cohort:
- Demographic variable: age, sex.
- Variables related to hepatitis C virus-infection: infection route, genotype, grade of hepatic fibrosis and method used for its determination, baseline Child-Pugh index in patients with cirrhosis, previous hepatic decompensations.
- Variables related to HIV-infection: CDC clinical category, HIV viral load, CD4 cell count, previous and new antiretroviral drugs.
- Blood test: AST, ALT platelets, cholesterol, bilirubin, gamma-glutamyltransferase, alkaline phosphatase, creatinine.
- Other variables: alcohol intake, self-reported adverse events, abnormal clinical findings.
- Cause of discontinuing antiviral when applicable.
Endpoints
- Primary endpoint: Emergence of grade 3-4 TEs/grade 4 TBEs (hepatic toxicity) from baseline to week 48.
- Secondary endpoints
- Emergence of hepatic adverse events.
- Drug interruptions due to liver toxicity.
- Development of hepatic decompensations.
- CD4 and viral load changes from baseline to week 48.
- Keywords
- HIV HCV antiretroviral
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Safety of the three-drug combination TDF/FTC/RPV | A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatic events
Number of patients with grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Measured: First 48 weeks of antiretroviral therapy
Secondary outcomes (2)
Comparison of hepatic events between exposed and unexposed to Eviplera®
We evaluated the following parameters between subjets exposed and unexposed to Eviplera®
- Incidence of hepatic toxicity
- Incidence of hepatic adverse events.
- Proportion of subjects who interrupt treatment due to liver toxicity according to Eviplera® exposure
We will evaluated this parameters taking account the impact of baseline liver fibrosis/cirrhosis on liver toxicity.
Measured: First 48 weeks of antiretroviral therapy
Viral Kinetics and Immune response
Viral kinetics.- We compare the viral load between patients exposed and not exposed with Eviplera.
Immune response.- We compare number of CD4 cells between patients exposed and not exposed with Eviplera
Measured: 48 weeks of antiretroviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected SubjectsStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Juan Antonio Pineda Vergara, Study chair, Hospital Universitario Virgen de ValmeAntonio Rivero Román, Study chair, Hospital General Universitario Reina Sofía de MurciaDolores Merino Muñoz, Principal investigator, Complejo Hospitalario de Especialidades Juan Ramón JimenezMaría José Rios Villega, Principal investigator, Hospital Universitario Virgen MacarenaFrancisco Téllez Pérez, Principal investigator, Hospital La Línea de la ConcepciónInés Pérez Camacho, Principal investigator, Hospital de PonienteAntonio Collado Romacho, Principal investigator, Complejo Hospitario TorrecárdenasJosefa Ruiz Morales, Principal investigator, Hospital Universitario Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196064
- Sponsor's protocol ID
- hEPAtic
- Acronym
- hEPAtic
- Status last verified
- Aug 2015
- First submitted
- 15 Jul 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort." hEPAtic Study.
- ClinicalTrials.gov ID
- NCT02196064
- Acronym / sponsor ID
- hEPAtic / hEPAtic
- Keywords
- HIV HCV antiretroviral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Jul 2014 (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.
To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Detailed description
This is a retrospective analysis of the prospective multicenter, observational "HEPAVIR HEPATIC SAFETY Cohort" (NCT01908660), in which the hepatic safety of the three-drug combination TDF/FTC/RPV will be assessed. A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
The main objective is to evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
Variables collected within in the cohort:
- Demographic variable: age, sex.
- Variables related to hepatitis C virus-infection: infection route, genotype, grade of hepatic fibrosis and method used for its determination, baseline Child-Pugh index in patients with cirrhosis, previous hepatic decompensations.
- Variables related to HIV-infection: CDC clinical category, HIV viral load, CD4 cell count, previous and new antiretroviral drugs.
- Blood test: AST, ALT platelets, cholesterol, bilirubin, gamma-glutamyltransferase, alkaline phosphatase, creatinine.
- Other variables: alcohol intake, self-reported adverse events, abnormal clinical findings.
- Cause of discontinuing antiviral when applicable.
Endpoints
- Primary endpoint: Emergence of grade 3-4 TEs/grade 4 TBEs (hepatic toxicity) from baseline to week 48.
- Secondary endpoints
- Emergence of hepatic adverse events.
- Drug interruptions due to liver toxicity.
- Development of hepatic decompensations.
- CD4 and viral load changes from baseline to week 48.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety of the three-drug combination TDF/FTC/RPV | – | –A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 176 patients will be included in this study, as well as 352 patients naive for RPV who initiated any ART that does not include RPV, who will serve as control group.
Key inclusion criteria (4 listed)
- ≥ 18 years old.
- Chronic HIV-1 infection, as diagnosed on the basis of the presence of serum HIV antibodies detected by EIA and western-blot.
- Chronic HCV infection as proven by detecting HCV antibodies in plasma, as well as detectable plasma HCV-RNA by PCR.
- To start a new ART regimen during the study period.
Key exclusion criteria (6 listed)
- Subjects with hepatotoxic events in the 2 months previous to Eviplera® treatment.
- Acute infections or uncontrolled chronic infection in the two months previous to Eviplera® treatment.
- Concomitant use of any drug with potential drug-drug interaction with Eviplera®.
- Documented resistance to study drugs.
- Concomitant therapy including anti-HCV agents, cytotoxic chemotherapy or immunosuppressors during Eviplera® treatment.
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
Incidence of hepatic events
Time frame: First 48 weeks of antiretroviral therapy
Number of patients with grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.
2 secondary outcomes
Comparison of hepatic events between exposed and unexposed to Eviplera®
Time frame: First 48 weeks of antiretroviral therapy
Viral Kinetics and Immune response
Time frame: 48 weeks of antiretroviral therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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.
Juan Antonio Pineda Vergara study chair
Hospital Universitario Virgen de Valme
Antonio Rivero Román study chair
Hospital General Universitario Reina Sofía de Murcia
Dolores Merino Muñoz principal investigator
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatic events (time frame: First 48 weeks of antiretroviral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2015.