Hepatitis C InfectionPhase 4NCT02247440
HCV-HIV Co-infected Patient Cohort in Thailand
A Phase 4 study testing Peg-interferon + ribavirin under HIV physician supervision in people with Hepatitis C Infection and HIV, run by Institut de Recherche pour le Developpement at 5 sites in Thailand.
Trial summary
This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection, HIV
- What is being tested?
- Peg-interferon + ribavirin under HIV physician supervision
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesThailand
- Study dates
- Aug 2014to Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion).
Who cannot join
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance <50 mL/min (Cockcroft)
- Disease associated with the immune system
Show all 10Show fewer
- Significant heart problems
- Severe neuropsychiatric conditions Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
- Other exclusion criteria related to the use of ribavirin and peg-interferon
- Any conditions that, in the investigator's judgment, may compromise the follow up.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Thailand5 sites
Nakornping Hospital
Chiang Mai, 50180
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000
Chonburi Hospital
Chon Buri, 20000
Samutsakhon Hospital
Samut Sakhon, 74000
Sanpatong Hospital
San Pa Tong, Chiang Mai, 50120
About this study
Official title: Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand
This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment.
Chronic hepatitis C virus (HCV) infection is responsible for several severe and life threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV replication is suppressed on antiretroviral treatment.
Read more
The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured are no longer contagious to other individuals, therefore widespread access to HCV treatment may contribute to the control of the HCV epidemic.
A combination of injectable pegylated-interferon with oral ribavirin is currently the recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They are administered for 24 weeks in HCV mono-infected patients but need to be administered for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter treatment.
PRIMARY OBJECTIVE
- To determine the percentage of patients according to genotypes with sustained virological response 6 months after treatment discontinuation (SVR).
HCV TREATMENT
- Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)
- Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of anemia.
A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a first part (starting in August 2014) and 45 patients in a second part, depending on funding.
Read the detailed description
Study Population Screening: HIV infected patients with a positive anti-HCV test will be approached for screening if they are at least 18 years old, participate in the PHPT cohort study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3 if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving antiretroviral treatment.
Inclusion Criteria
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion). Main exclusion criteria
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance <50 mL/min (Cockcroft)
- Disease associated with the immune system
- Significant heart problems
- Severe neuropsychiatric conditions
- Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
- Other exclusion criteria related to the use of ribavirin and peg-interferon
- Any conditions that, in the investigator's judgment, may compromise the follow up.
Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6 months after treatment discontinuation.
Treatment will be discontinued earlier in patients who do not achieve early viral response, i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.
- Conditions
- Hepatitis C Infection, HIV
- Being tested
- Peg-interferon + ribavirin under HIV physician supervision
- Keywords
- HCV, HIV, Thailand, pegylated interferon, ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-interferon + ribavirin under HIV physician supervisionDrug
Also called Pegintron, Rebetol
Peg-interferon + ribavirin under HIV physician supervision
| Study group | Role | What they receive |
|---|---|---|
| PegINF-ribavirin | Experimental | Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
2. For genotypes 1, 4, 5 and 6:
* 800 mg/day, if bodyweight <65 kg,
* 1000 mg/day, if bodyweight between 66-80 kg,
* 1200 mg/day, if bodyweight between 81-105 kg,
* 1400 mg/day, if bodyweight >105 kg.
Duration: 48 weeks Receives: Drug: Peg-interferon + ribavirin under HIV physician supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,
Measured: 6 months after end of treatment, i.e. 1.5 years after treatment initiation
Secondary outcomes (2)
Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).
Measured: From initiation of treatment to 6 months after treatment discontinuation
Number of Participants Grouped by HIV-1 RNA Concentrations
Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).
Measured: At time of treatment discontinuation (whatever its date) and 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C InfectionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Principal investigator, GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement
- Investigators
- Gonzague Jourdain, MD, PhD, Principal investigator, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247440
- Sponsor's protocol ID
- PHPT-HCV
- Status last verified
- Feb 2019
- First submitted
- 9 Sep 2014
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand
- ClinicalTrials.gov ID
- NCT02247440
- Acronym / sponsor ID
- PHPT-HCV
- Conditions
- Hepatitis C Infection, HIV
- Keywords
- HCV, HIV, Thailand, pegylated interferon, ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Ministry of Health, Thailand
- Study start
- Aug 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment.
Chronic hepatitis C virus (HCV) infection is responsible for several severe and life threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV replication is suppressed on antiretroviral treatment.
The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured are no longer contagious to other individuals, therefore widespread access to HCV treatment may contribute to the control of the HCV epidemic.
A combination of injectable pegylated-interferon with oral ribavirin is currently the recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They are administered for 24 weeks in HCV mono-infected patients but need to be administered for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter treatment.
PRIMARY OBJECTIVE
- To determine the percentage of patients according to genotypes with sustained virological response 6 months after treatment discontinuation (SVR).
HCV TREATMENT
- Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)
- Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of anemia.
A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a first part (starting in August 2014) and 45 patients in a second part, depending on funding.
Detailed description
Study Population Screening: HIV infected patients with a positive anti-HCV test will be approached for screening if they are at least 18 years old, participate in the PHPT cohort study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3 if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving antiretroviral treatment.
Inclusion Criteria
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion). Main exclusion criteria
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance <50 mL/min (Cockcroft)
- Disease associated with the immune system
- Significant heart problems
- Severe neuropsychiatric conditions
- Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
- Other exclusion criteria related to the use of ribavirin and peg-interferon
- Any conditions that, in the investigator's judgment, may compromise the follow up.
Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6 months after treatment discontinuation.
Treatment will be discontinued earlier in patients who do not achieve early viral response, i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegINF-ribavirin | Experimental | Drug: Peg-interferon + ribavirin under HIV physician supervisionPeg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week Ribavirin initial dosing in the morning and in the evening: 1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily). 2. For genotypes 1, 4, 5 and 6: * 800 mg/day, if bodyweight <65 kg, * 1000 mg/day, if bodyweight between 66-80 kg, * 1200 mg/day, if bodyweight between 81-105 kg, * 1400 mg/day, if bodyweight >105 kg. Duration: 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
- Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
- Negative pregnancy test (on the day of inclusion).
Key exclusion criteria (10 listed)
- Anemia and thrombocytopenia
- Severe liver damage, advanced stage cirrhosis or cancer
- Uncontrolled diabetes, Uncontrolled thyroid dysfunction
- Retinopathy
- Creatinine clearance <50 mL/min (Cockcroft)
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 |
|---|---|---|
| Peg-interferon + ribavirin under HIV physician supervisionAlso: Pegintron, RebetolPeg-interferon + ribavirin under HIV physician supervision | Drug | PegINF-ribavirin |
Primary outcome
Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
Time frame: 6 months after end of treatment, i.e. 1.5 years after treatment initiation
Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,
2 secondary outcomes
Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
Time frame: From initiation of treatment to 6 months after treatment discontinuation
Number of Participants Grouped by HIV-1 RNA Concentrations
Time frame: At time of treatment discontinuation (whatever its date) and 6 months thereafter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gonzague Jourdain, MD, PhD principal investigator
Institut de Recherche pour le Developpement
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peg-interferon + ribavirin under HIV physician supervision in people with Hepatitis C Infection and HIV, run by Institut de Recherche pour le Developpement at 5 sites in Thailand.
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 3 inclusion and 10 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation (time frame: 6 months after end of treatment, i.e. 1.5 years after treatment initiation). 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 3 Jun 2019.