Hepatitis CPhase 4NCT01838772
HCV Treatment in HIV Co-Infected Patients in Asia
A Phase 4 study testing Pegylated-Interferon and Ribavirin in people with Hepatitis C and HIV, run by amfAR, The Foundation for AIDS Research at 4 sites in 4 countries.
Trial summary
The purpose of this study is to assess the effectiveness and tolerability of hepatitis C virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia through a pilot model of care for treatment of HCV in resource-limited settings. 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?
- Pegylated-Interferon and Ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2013to Sep 2016
- Phase
- Phase 4
- 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
Who may be able to join
- 18 years of age or older
- Confirmed HIV infection by antibody and/or virologic testing
- Chronic HCV infection with any genotype, confirmed by a positive anti-HCV antibody test obtained at least six months prior to screening, and detectable HCV RNA at screening.
- Stable ART in patients with CD4 counts between 200-350 cells/µl at the time of screening, OR stable ART, or no ART in patients with CD4 counts above 350 cells/µl at the time of screening.
- Liver fibrosis stage >F1 (defined as a fibrosis score >=7.5 KPa by Fibroscan®, or through histological examination of a liver biopsy specimen).
- Compensated liver disease, with a Child-Pugh grade no greater than A, and:
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- No ascites (current or ever)
- No hepatic encephalopathy (current or ever)
- No bleeding varices (current or ever)
- Patients with suspected cirrhosis (Fibroscan® >=13.0 KPa or through histological examination of a liver biopsy specimen) must have an abdominal ultrasound and alpha fetoprotein test result without evidence of hepatocellular carcinoma within two months prior to screening.
- Negative urine or blood pregnancy test for women of childbearing potential documented within the 24-hour period prior to the first dose of study drug.
- All males and females of reproductive age and potential must agree to use effective contraception during treatment and during the 24 weeks after the end of treatment.
- Voluntarily signed informed consent form.
- Willingness to start therapy and to adhere to the requirements of the study visits schedule.
Who cannot join
- Any history of previous Interferon or ribavirin therapy.
- Known active bacterial infection.
- Ongoing treatment for mycobacterial infection.
- CD4 count <200 cells/ µl.
- Current pregnancy or breast feeding.
- Male partners of women who are pregnant.
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- Evidence of a medical condition other than HCV identified as another significant cause of chronic liver disease (e.g., severe alcoholic liver disease, toxin exposures, metabolic liver disease, autoimmune hepatitis).
- Active drug use or alcohol consumption that is judged by the study physician to potentially compromise treatment safety.
- Hemoglobin <11 g/dL in women or <12 g/dL in men.
- ALT (SGPT) or AST (SGOT) level >10 times the upper normal limit.
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3.
- Serum creatinine level >1.5 times the upper normal limit.
- Inadequately controlled thyroid dysfunction (i.e., TSH and T4 levels out of normal ranges).
- Ongoing severe psychiatric disease (e.g., depression) as judged by the study physician to potentially compromise treatment safety.
- Uncontrolled seizure disorder.
- Concomitant use of didanosine.
- Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
- History of severe chronic pulmonary disease, cardiac disease, malignancy, or other severe illness, which would make the patient, in the opinion of the study physician, unsuitable for treatment administration and participation in the study.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Effectiveness and Tolerability of Hepatitis C Treatment in HIV Co-infected Patients in Routine Care Services in Asia: A Pilot Model of Care Project
The purpose of this study is to assess the effectiveness and tolerability of hepatitis C virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia through a pilot model of care for treatment of HCV in resource-limited settings.
Read the detailed description
It is estimated that 130-170 million people are chronically infected with the hepatitis C virus (HCV). Out of the 33 million HIV-infected people around the world, it is estimated that at least 5 million are also infected with HCV. HCV therapy with Pegylated-interferon and ribavirin is between 50-90% effective to achieve cure, depending on the virus genotype and patient characteristics, such as ethnicity and IL28B polymorphism. Treatment studies in HIV-uninfected populations have shown that Asian patients experience higher treatment response rates than Caucasians. Unfortunately, although HCV therapy is routinely offered in resource-rich settings, it is essentially inaccessible in resource-limited settings (RLS), where most of the people infected with the virus live. One of the bottlenecks to increasing implementation of HCV therapy in RLS is that therapy is currently expensive and deemed complex for broad implementation in RLS. Through this project and study, TREAT Asia aims to build a regional approach in Asia to establish the feasibility of HCV therapy in HIV-infected patients in RLS, and implement an innovative model of HCV-HIV care that can be expanded in the future.
Patients with HIV infection and documented HCV antibodies under routine HIV care at the four study sites will have HCV RNA testing. Patients with confirmed chronic HCV infection will have HCV genotype and IL28B testing, as well as liver disease assessment with Fibroscan®. Patients with chronic HCV co-infection with any genotype and meeting all other treatment eligibility criteria will be offered treatment with pegylated-interferon and ribavirin through an open-label single arm study. A total of up to 200 patients will be enrolled into the study. Patients will receive intensive treatment preparedness counseling, and ongoing treatment adherence support. Most patients will receive treatment for a total of 48 weeks, but patients with HCV genotype 2 and 3, moderate liver fibrosis, and rapid virological response (negative HCV RNA by four weeks of therapy) will receive 24 weeks of therapy. The primary endpoint of interest will be the proportion of patients achieving sustained virological response, defined as an undetectable HCV RNA 24 weeks after treatment completion.
- Conditions
- Hepatitis C, HIV
- Being tested
- Pegylated-Interferon and Ribavirin
- Keywords
- HCV and HIV co-infection
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated-Interferon and RibavirinDrug
Also called PegIntron, Rebetol
This is an open-label, single arm demonstration study. Intervention consists in treatment with Pegylated-interferon (Peg-Intron®, 1.5 microgr/kg/week, as subcutaneous injection) and ribavirin (Rebetol®, weight-based dosing, 2-daily doses) for 48 weeks, or 24 weeks for patients with genotype 2 and 3, moderate liver fibrosis, and rapid virological response.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated-Interferon and Ribavirin | Other | Pegylated-interferon 1.5 microgr/kg, subcutaneously, once weekly for 48 weeks*. Ribavirin, weight-based dosage, divided in two daily doses for 48 weeks*.
*patients with genotype 2 and 3, moderate liver fibrosis, and rapid virologic response will receive therapy for 24 weeks. Receives: Drug: Pegylated-Interferon and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with sustained virological response (SVR), defined as an undetectable HCV RNA, 24 weeks after completion of therapy
Measured: 24 weeks after completion of therapy
Secondary outcomes (5)
Proportion of patients with Rapid Virological Response (RVR)
Measured: 4 weeks of therapy
Proportion of patients with Early Virological Response (EVR)
Measured: 12 weeks of therapy
Proportion of patients with End of Treatment Response (ETR)
Measured: Up to 48 weeks of therapy
Proportions of patients who discontinue treatment prematurely
Measured: Up to 48 weeks of therapy
Clinical and laboratory safety parameters
The proportion of participants with all grades of adverse events will be summarized by severity and relation to study drugs.
Measured: Up to 48 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionSep 2016
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- amfAR, The Foundation for AIDS Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kirby Institute
- Responsible party
- Sponsor
- Investigators
- Nicolas Durier, MD, MPH, Principal investigator, TREAT Asia/ amfAR - The Foundation for AIDS ResearchGail Matthews, MD, PhD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838772
- Sponsor's protocol ID
- TA010
- Status last verified
- Oct 2016
- First submitted
- 5 Apr 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Hepatitis C Treatment in HIV Co-infected Patients in Routine Care Services in Asia: A Pilot Model of Care Project
- ClinicalTrials.gov ID
- NCT01838772
- Acronym / sponsor ID
- TA010
- Conditions
- Hepatitis C, HIV
- Keywords
- HCV and HIV co-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- amfAR, The Foundation for AIDS ResearchUniversity, hospital or other
- Collaborators
- Kirby Institute
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Apr 2013 (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.
The purpose of this study is to assess the effectiveness and tolerability of hepatitis C virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia through a pilot model of care for treatment of HCV in resource-limited settings.
Detailed description
It is estimated that 130-170 million people are chronically infected with the hepatitis C virus (HCV). Out of the 33 million HIV-infected people around the world, it is estimated that at least 5 million are also infected with HCV. HCV therapy with Pegylated-interferon and ribavirin is between 50-90% effective to achieve cure, depending on the virus genotype and patient characteristics, such as ethnicity and IL28B polymorphism. Treatment studies in HIV-uninfected populations have shown that Asian patients experience higher treatment response rates than Caucasians. Unfortunately, although HCV therapy is routinely offered in resource-rich settings, it is essentially inaccessible in resource-limited settings (RLS), where most of the people infected with the virus live. One of the bottlenecks to increasing implementation of HCV therapy in RLS is that therapy is currently expensive and deemed complex for broad implementation in RLS. Through this project and study, TREAT Asia aims to build a regional approach in Asia to establish the feasibility of HCV therapy in HIV-infected patients in RLS, and implement an innovative model of HCV-HIV care that can be expanded in the future.
Patients with HIV infection and documented HCV antibodies under routine HIV care at the four study sites will have HCV RNA testing. Patients with confirmed chronic HCV infection will have HCV genotype and IL28B testing, as well as liver disease assessment with Fibroscan®. Patients with chronic HCV co-infection with any genotype and meeting all other treatment eligibility criteria will be offered treatment with pegylated-interferon and ribavirin through an open-label single arm study. A total of up to 200 patients will be enrolled into the study. Patients will receive intensive treatment preparedness counseling, and ongoing treatment adherence support. Most patients will receive treatment for a total of 48 weeks, but patients with HCV genotype 2 and 3, moderate liver fibrosis, and rapid virological response (negative HCV RNA by four weeks of therapy) will receive 24 weeks of therapy. The primary endpoint of interest will be the proportion of patients achieving sustained virological response, defined as an undetectable HCV RNA 24 weeks after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated-Interferon and Ribavirin | Other | Drug: Pegylated-Interferon and RibavirinPegylated-interferon 1.5 microgr/kg, subcutaneously, once weekly for 48 weeks*. Ribavirin, weight-based dosage, divided in two daily doses for 48 weeks*. *patients with genotype 2 and 3, moderate liver fibrosis, and rapid virologic response will receive therapy for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age or older
- Confirmed HIV infection by antibody and/or virologic testing
- Chronic HCV infection with any genotype, confirmed by a positive anti-HCV antibody test obtained at least six months prior to screening, and detectable HCV RNA at screening.
- Stable ART in patients with CD4 counts between 200-350 cells/µl at the time of screening, OR stable ART, or no ART in patients with CD4 counts above 350 cells/µl at the time of screening.
- Liver fibrosis stage >F1 (defined as a fibrosis score >=7.5 KPa by Fibroscan®, or through histological examination of a liver biopsy specimen).
Key exclusion criteria (18 listed)
- Any history of previous Interferon or ribavirin therapy.
- Known active bacterial infection.
- Ongoing treatment for mycobacterial infection.
- CD4 count <200 cells/ µl.
- Current pregnancy or breast feeding.
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 |
|---|---|---|
| Pegylated-Interferon and RibavirinAlso: PegIntron, RebetolThis is an open-label, single arm demonstration study. Intervention consists in treatment with Pegylated-interferon (Peg-Intron®, 1.5 microgr/kg/week, as subcutaneous injection) and ribavirin (Rebetol®, weight-based dosing, 2-daily doses) for 48 weeks, or 24 weeks for patients with genotype 2 and 3, moderate liver fibrosis, and rapid virological response. | Drug | Pegylated-Interferon and Ribavirin |
Primary outcome
The proportion of patients with sustained virological response (SVR), defined as an undetectable HCV RNA, 24 weeks after completion of therapy
Time frame: 24 weeks after completion of therapy
5 secondary outcomes
Proportion of patients with Rapid Virological Response (RVR)
Time frame: 4 weeks of therapy
Proportion of patients with Early Virological Response (EVR)
Time frame: 12 weeks of therapy
Proportion of patients with End of Treatment Response (ETR)
Time frame: Up to 48 weeks of therapy
Proportions of patients who discontinue treatment prematurely
Time frame: Up to 48 weeks of therapy
Clinical and laboratory safety parameters
Time frame: Up to 48 weeks of 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 27 Oct 2016.
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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.
Nicolas Durier, MD, MPH principal investigator
TREAT Asia/ amfAR - The Foundation for AIDS Research
Gail Matthews, MD, PhD principal investigator
Kirby Institute
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated-Interferon and Ribavirin in people with Hepatitis C and HIV, run by amfAR, The Foundation for AIDS Research at 4 sites in 4 countries.
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 14 inclusion and 18 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia, Malaysia, Thailand, Vietnam. 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?
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?
The proportion of patients with sustained virological response (SVR), defined as an undetectable HCV RNA, 24 weeks after completion of therapy (time frame: 24 weeks after completion of 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 27 Oct 2016.