HCV Treatment in HIV Co-Infected Patients in Asia

NCT01838772 | Completed Phase 4

• 1 other identifier: TA010
• Study Type: interventional
• Target: 188
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Hepatitis C; HIV

Keywords

HCV and HIV co-infection

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with sustained virological response (SVR), defined as an undetectable HCV RNA, 24 weeks after completion of therapy

  24 weeks after completion of therapy

Secondary Outcomes (5)

• Proportion of patients with Rapid Virological Response (RVR)

  4 weeks of therapy

• Proportion of patients with Early Virological Response (EVR)

  12 weeks of therapy

• Proportion of patients with End of Treatment Response (ETR)

  Up to 48 weeks of therapy

• Proportions of patients who discontinue treatment prematurely

  Up to 48 weeks of therapy

• Clinical and laboratory safety parameters

  Up to 48 weeks of therapy

Study Arms (1)

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.

Drug: Pegylated-Interferon and Ribavirin

Interventions

Pegylated-Interferon and Ribavirin DRUG

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.

Also known as: PegIntron, Rebetol

Pegylated-Interferon and Ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• amfAR, The Foundation for AIDS Research: lead
• Kirby Institute: collaborator

Study Sites (4)

Cipto Mangunkusumo General Hospital

Jakarta, 10430, Indonesia

Location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

HIV-NAT/ Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

National Hospital for Tropical Diseases

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Nicolas Durier, MD, MPH

  TREAT Asia/ amfAR - The Foundation for AIDS Research

  PRINCIPAL INVESTIGATOR

• Gail Matthews, MD, PhD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 24, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

VN (1); TH (1); MY (1); ID (1)