Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV

University of Valencia

Status and phase

Unknown

Phase 4

Conditions

Co-Infection HIV-HCV

Chronic Hepatitis C

Treatments

Drug: Peg interferon + Ribavirin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00611819

2005-000203-34

KHRONOS

Details and patient eligibility

About

The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.

Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.

In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.

In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.

In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.

Full description

Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.

Enrollment

59 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients of 18-65 years of age
Serologic evidence of chronic hepatitis C infection by detectable plasma HCV-RNA
Serologic evidence of HIV-1 infection by ELISA and Western-blot
Stable status of HIV-1 infection in the opinion of the investigator
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. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
Willingness to give written informed consent and willingness to participate to and comply with the study

Exclusion criteria

Women with ongoing pregnancy or breast feeding
IFN or ribavirin therapy at any previous time
Any investigational drug <6 weeks prior to the first dose of study drug
History or other evidence of a medical condition associated with chronic liver disease other than HCV
Hepatocarcinoma observed
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
Absolute neutrophil count <1500 cells/mm3
Hgb <12 g/dL in women or 13 g/dL in men or any patient for whom anemia would be medically problematic
Hemoglobinopathy (e.g. thalassemia) or any other cause of or tendency for hemolysis
Platelet count <90000 cells/mm3
Serum creatinine level >1.5 times the upper limit of normal at screening
History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
History of a severe seizure disorder or current anticonvulsant use
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
History or other evidence of chronic pulmonary disease associated with functional limitation
History of significant cardiac disease that could be worsened by acute anemia
History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
Evidence of severe retinopathy
History of major organ transplantation with an existing functional graft
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Drug use within 6 months of 1st dose and excessive alcohol consumption