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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530972
First Posted: September 18, 2007
Last Update Posted: September 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Carlos III, Madrid
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C HIV Infections Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • % of patients with RNA-HCV undetectable [ Time Frame: 24 weeks after end of treatment ]

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 [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ]
  • Ribavirin levels [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ]
  • Impact of dose reduction peg-interferon and/or ribavirin [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ]

Enrollment: 50
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginterferon alfa-2a plus ribavirin 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)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530972


Locations
Spain
Hospital Carlos III
Madrid., Madrid, Spain, 28029
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
  More Information

Responsible Party: Vicente Soriano, Hospital Carlos III
ClinicalTrials.gov Identifier: NCT00530972     History of Changes
Other Study ID Numbers: 2005-001192-34
First Submitted: September 17, 2007
First Posted: September 18, 2007
Last Update Posted: September 7, 2009
Last Verified: September 2009

Keywords provided by Hospital Carlos III, Madrid:
co-infected HCV/HIV
relapsers

Additional relevant MeSH terms:
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs


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