Hepatitis CHCV-MonitoringNCT02628691
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia
An observational study of Hepatitis C and HIV, run by Institute of Tropical Medicine, Belgium at 1 site in Cambodia.
Trial summary
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV
- What is being tested?
- Liver fibrosis progression
- How many people
- 70 participants
- Where
- 1 siteCambodia
- Study dates
- 17 Dec 2015to 12 Jul 2017
- 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: Adult HIV-infected patients of the SHCH cohort who have chronic HCV infection (all genotypes) with no-to-moderate hepatic fibrosis and not considered in immediate need of HCV treatment.
Who may be able to join
- Male and females
- ≥18 years
- Documented HIV infection
- Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
- Absence of advanced liver disease or clinical signs of extra-hepatic disease:
- F0-F2 (< 9,5 kPa) established by transient elastography, and
- No clinical signs of extra-hepatic disease
- Not on HCV antiviral treatment
Who cannot join
- Currently on/or history of hepatitis C treatment
- Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
- Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
Read more
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study.
Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Read the detailed description
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
The study will be conducted in Sihanouk Hospital Center of Hope (SHCH) in Phnom Penh (Cambodia), more particularly within the ambulatory HIV clinic setting. SHCH is a non-governmental hospital providing comprehensive HIV care free of charge since March 2003, as part of the national antiretroviral (ARV) program. They dispose of an experienced HIV clinician, counselor and social worker team and several operational research studies were conducted within this setting.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. No formal sample size is being calculated. The final sample will comprise all patients fulfilling the inclusion criteria.
The data collected from the HCV-Epi study will be considered as the baseline visit for the HCV-Monitoring study. Thereafter, visits are planned at 6, 12, 18 and 24 months follow-up. These patient visits will, beyond the habitual HIV follow-up, integrate a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
- Conditions
- Hepatitis C, HIV
- Being tested
- Liver fibrosis progression
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver fibrosis progressionOther
A history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed. Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
| Study group | Role | What they receive |
|---|---|---|
| HCV coinfection with no-to-moderate fibrosis | Not described Receives: Other: Liver fibrosis progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term progression to advanced liver fibrosis
Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).
Measured: 30 months
Secondary outcomes (9)
Demographic characteristics
Demographic baseline characteristics of the study participants
Measured: Baseline
Clinical characteristics
Clinical baseline characteristics of the study participants
Measured: Baseline
Laboratory characteristics
Laboratory baseline characteristics of the study participants
Measured: Baseline
Progression to cirrhosis
Proportion of patients who progress to cirrhosis ((F=4, > 14 kPa)
Measured: 30 months
Liver stiffness measurement
Median Liver stiffness measurement increase per year
Measured: 30 months
Changes in fibrosis stage scores
Change in Metavir score (regression/progression, number of stages difference)
Measured: 30 months
Diagnostic accuracy of non-invasive serum bio-markers: APRI
Predictive value of APRI to identify a shift from (≤F2) to advanced fibrosis (≥3)
Measured: 30 months
Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
Predictive value of FIB-4 to identify a shift from (≤F2) to advanced fibrosis (≥3)
Measured: 30 months
Predictive factors for liver fibrosis progression
Factors associated with rapid fibrosis progression in HCV/HIV coinfected patients with initial mild to moderate fibrosis: age, gender, alcohol use, smoking, coffee consumption, comorbidities, liver enzymes, HCV viral load, HIV viral load, and ART exposure
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start17 Dec 2015
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Why it stopped: All patients were started on HCV treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Anja De Weggheleire, MD, Study director, Institute of Tropical Medicine, Antwerp, BelgiumAn Sokkab, MD, Principal investigator, Sihanouk Hospital Center of HOPE (SHCH), Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628691
- Sponsor's protocol ID
- HCV-Monitoring
- Acronym
- HCV-Monitoring
- Status last verified
- Aug 2017
- First submitted
- 25 Nov 2015
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
- ClinicalTrials.gov ID
- NCT02628691
- Acronym / sponsor ID
- HCV-Monitoring / HCV-Monitoring
- Conditions
- Hepatitis C, HIV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All patients were started on HCV treatment
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, University Hospital, Antwerp
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 11 Dec 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.
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study.
Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Detailed description
Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.
Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.
The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.
The study will be conducted in Sihanouk Hospital Center of Hope (SHCH) in Phnom Penh (Cambodia), more particularly within the ambulatory HIV clinic setting. SHCH is a non-governmental hospital providing comprehensive HIV care free of charge since March 2003, as part of the national antiretroviral (ARV) program. They dispose of an experienced HIV clinician, counselor and social worker team and several operational research studies were conducted within this setting.
All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.
Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. No formal sample size is being calculated. The final sample will comprise all patients fulfilling the inclusion criteria.
The data collected from the HCV-Epi study will be considered as the baseline visit for the HCV-Monitoring study. Thereafter, visits are planned at 6, 12, 18 and 24 months follow-up. These patient visits will, beyond the habitual HIV follow-up, integrate a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV coinfection with no-to-moderate fibrosis | – | Other: Liver fibrosis progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HIV-infected patients of the SHCH cohort who have chronic HCV infection (all genotypes) with no-to-moderate hepatic fibrosis and not considered in immediate need of HCV treatment.
Key inclusion criteria (8 listed)
- Male and females
- ≥18 years
- Documented HIV infection
- Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
- Absence of advanced liver disease or clinical signs of extra-hepatic disease:
Key exclusion criteria (3 listed)
- Currently on/or history of hepatitis C treatment
- Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
- Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver fibrosis progressionA history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed. Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load. | Other | HCV coinfection with no-to-moderate fibrosis |
Primary outcome
Short-term progression to advanced liver fibrosis
Time frame: 30 months
Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).
9 secondary outcomes
Demographic characteristics
Time frame: Baseline
Clinical characteristics
Time frame: Baseline
Laboratory characteristics
Time frame: Baseline
Progression to cirrhosis
Time frame: 30 months
Liver stiffness measurement
Time frame: 30 months
Changes in fibrosis stage scores
Time frame: 30 months
Diagnostic accuracy of non-invasive serum bio-markers: APRI
Time frame: 30 months
Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
Time frame: 30 months
Predictive factors for liver fibrosis progression
Time frame: 30 months
Results and safety
The study was stopped early (reason given: All patients were started on HCV treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
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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.
Anja De Weggheleire, MD study director
Institute of Tropical Medicine, Antwerp, Belgium
An Sokkab, MD principal investigator
Sihanouk Hospital Center of HOPE (SHCH), Cambodia
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 Hepatitis C and HIV, run by Institute of Tropical Medicine, Belgium at 1 site in Cambodia.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Aug 2017. 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 Cambodia. 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 was stopped early (reason given: All patients were started on HCV treatment). Results are not available in the source record.
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?
Short-term progression to advanced liver fibrosis (time frame: 30 months). 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 23 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.