HCV Treatment in HIV Co-Infected Patients in Asia

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: amfAR, The Foundation for AIDS Research
• Collaborator: Kirby Institute
• Treatments: Interferons; Ribavirin

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 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.