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

Hospital Carlos III, Madrid

Status and phase: Completed; Phase 4

Conditions: HIV Infections; Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight

Study type: Interventional

Funder types: Other

Identifiers

NCT00530972

2005-001192-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Peginterferon alfa-2a plus ribavirin

Experimental group

Treatment:

Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight