Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies

NCT ID: NCT00530972

Last Updated: 2009-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-12-31

Brief Summary

To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.

Detailed Description

An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.

All co-infected patients should be an opportunity of retreatment with actually therapies.

Conditions

Chronic Hepatitis C; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon alfa-2a plus ribavirin

Group Type: EXPERIMENTAL

Peginterferon alfa-2a plus ribavirin adjusted to body weight

Intervention Type: DRUG

PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg \<75 kg, 1200 mg \>75 kg)

Interventions

Peginterferon alfa-2a plus ribavirin adjusted to body weight

PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg \<75 kg, 1200 mg \>75 kg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients between 18 and 65 years of age
• Anti-HCV positive
• Detectable plasma HCV-RNA
• Relapsers after treatment with interferon o peginterferon +/- ribavirin
• HIV positive
• CD4 >/= 200 cell
• Patients on clinically stable liver disease with:

• Hgb >/= 12 g/dL in women or 13 g/dL in men
• Leucocytes >/= 3000 mm3
• Neutrophil count (ANC) >/= 1500 cells/mm3
• Platelet count >/= 100.000 cells/mm3
• Normal prothrombin, bilirubin, albumin, creatinine and uric acid
• HBsAg negative
• With antecedents of diabetes or hypertension is necessary an previous ocular exploration

Exclusion Criteria

• Women with ongoing pregnancy or breast feeding
• Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
• Hemochromatosis
• Deficit of alfa-1 antitrypsin
• Wilson disease
• Alcoholic liver disease
• Autoimmune hepatitis
• Hepatitis by toxin exposures
• Hepatitis by obesity
• Hemoglobinopathy (e.g. thalassemia)
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Hepatocarcinoma observed in the liver ecography.
• 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 significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
• Diabetes Mellitus
• 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
• Drug use within 6 months of 1st dose and excessive alcohol consumption.
• Concomitant treatment with ddI
• Male partners of women who are pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Carlos III, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Hospital Carlos III

Principal Investigators

Vicente Soriano, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Carlos III. Madrid. Spain

Locations

Hospital Carlos III

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

2005-001192-34

Identifier Type: -

Identifier Source: org_study_id