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

HIV Infections Clinical Trial

— PILOT-NR  

Official title:

Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530972
• Other study ID #: 2005-001192-34
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2007
• Last updated: September 4, 2009
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: Hospital Carlos III, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Spain	Hospital Carlos III	Madrid.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Carlos III, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with RNA-HCV undetectable		24 weeks after end of treatment	No
Secondary	% of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy		At weeks 4, 12, 24 and 48 on treatment	No
Secondary	Ribavirin levels		At weeks 4, 12, 24 and 48 on treatment	No
Secondary	Impact of dose reduction peg-interferon and/or ribavirin		At weeks 4, 12, 24 and 48 on treatment	No