Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

HCV Treatment in HIV Co-Infected Patients in Asia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by amfAR, The Foundation for AIDS Research
Sponsor:
Collaborator:
Kirby Institute
Information provided by (Responsible Party):
amfAR, The Foundation for AIDS Research
ClinicalTrials.gov Identifier:
NCT01838772
First received: April 5, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
HIV
Drug: Pegylated-Interferon and Ribavirin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by amfAR, The Foundation for AIDS Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with Rapid Virological Response (RVR) [ Time Frame: 4 weeks of therapy ] [ Designated as safety issue: No ]
  • Proportion of patients with Early Virological Response (EVR) [ Time Frame: 12 weeks of therapy ] [ Designated as safety issue: No ]
  • Proportion of patients with End of Treatment Response (ETR) [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: No ]
  • Proportions of patients who discontinue treatment prematurely [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: Yes ]
  • Clinical and laboratory safety parameters [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: Yes ]
    The proportion of participants with all grades of adverse events will be summarized by severity and relation to study drugs.


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pegylated-Interferon and Ribavirin

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.

Drug: Pegylated-Interferon and Ribavirin
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.
Other Names:
  • PegIntron
  • Rebetol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

  • 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.
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838772

Contacts
Contact: Nicolas Durier, MD, MPH +662 663 7561 ext 105 nicolas.durier@treatasia.org

Locations
Indonesia
Cipto Mangunkusumo General Hospital Recruiting
Jakarta, Indonesia, 10430
Principal Investigator: Evy Yunihastuti, MD, PhD         
Malaysia
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Principal Investigator: Adeeba Kamarulzaman, MD         
Thailand
HIV-NAT/ Thai Red Cross AIDS Research Center Recruiting
Bangkok, Thailand, 10330
Principal Investigator: Kiat Ruxrungtham, MD         
Vietnam
National Hospital for Tropical Diseases Recruiting
Hanoi, Vietnam
Principal Investigator: Kinh Van Nguyen, MD         
Sponsors and Collaborators
amfAR, The Foundation for AIDS Research
Kirby Institute
Investigators
Principal Investigator: Nicolas Durier, MD, MPH TREAT Asia/ amfAR - The Foundation for AIDS Research
Principal Investigator: Gail Matthews, MD, PhD The Kirby Institute, University of New South Wales
  More Information

No publications provided

Responsible Party: amfAR, The Foundation for AIDS Research
ClinicalTrials.gov Identifier: NCT01838772     History of Changes
Other Study ID Numbers: TA010
Study First Received: April 5, 2013
Last Updated: March 12, 2014
Health Authority: Australia: Human Research Ethics Committee
Indonesia: Ethics Committee
Malaysia: Institutional Review Board
Thailand: Ethical Committee
United States: Institutional Review Board
Vietnam: Ministry of Health

Keywords provided by amfAR, The Foundation for AIDS Research:
HCV and HIV co-infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014