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

Primary Purpose

Chronic Hepatitis C, HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Peginterferon alfa-2a plus ribavirin adjusted to body weight
Sponsored by
Hospital Carlos III, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring co-infected HCV/HIV, relapsers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Carlos III

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peginterferon alfa-2a plus ribavirin

Arm Description

Outcomes

Primary Outcome Measures

% of patients with RNA-HCV undetectable

Secondary Outcome Measures

% of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy
Ribavirin levels
Impact of dose reduction peg-interferon and/or ribavirin

Full Information

First Posted
September 17, 2007
Last Updated
September 4, 2009
Sponsor
Hospital Carlos III, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT00530972
Brief Title
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Carlos III, Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, HIV Infections
Keywords
co-infected HCV/HIV, relapsers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon alfa-2a plus ribavirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a plus ribavirin adjusted to body weight
Intervention Description
PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
Primary Outcome Measure Information:
Title
% of patients with RNA-HCV undetectable
Time Frame
24 weeks after end of treatment
Secondary Outcome Measure Information:
Title
% of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy
Time Frame
At weeks 4, 12, 24 and 48 on treatment
Title
Ribavirin levels
Time Frame
At weeks 4, 12, 24 and 48 on treatment
Title
Impact of dose reduction peg-interferon and/or ribavirin
Time Frame
At weeks 4, 12, 24 and 48 on treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Soriano, Dr
Organizational Affiliation
Hospital Carlos III. Madrid. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Carlos III
City
Madrid.
State/Province
Madrid
ZIP/Postal Code
28029
Country
Spain

12. IPD Sharing Statement

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

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