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

Chronic Hepatitis C Clinical Trial

Official title:

Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00611819
• Other study ID #: KHRONOS
• Secondary ID: 2005-000203-34
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 25, 2008
• Last updated: January 25, 2008
• Start date: November 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2008
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Co-Infection HIV-HCV
• Coinfection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peg interferon + Ribavirin
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
• Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital General de Castellón	Castellón
Spain	Hospital de Elche	Elche	Alicante
Spain	Hospital de Gandia	Gandia	Valencia
Spain	Hospital Clínico San Cecilio	Granada
Spain	Hospital Infanta Elena	Huelva
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital la Paz	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital General de Murcia	Murcia
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital la Fe	Valencia
Spain	Hospital Xeral-Cíes	Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with RNA-HCV undetectable 24 weeks		24 weeks after the end of treatment	Yes
Secondary	% of patients at the end of treatment		48 weeks of treatmemt	Yes