Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Pilot Study of Patients Chronic Hepatitis C in co-Infected HIV Patients Relapsers After Previous Therapies (PILOT-NR)
This study is currently recruiting participants.
Verified by Hospital Carlos III, Madrid, September 2007
Sponsored by: Hospital Carlos III, Madrid
Information provided by: Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier: NCT00530972
  Purpose

To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who has relapser after treatment with previous therapies based in Interferon.


Condition Intervention Phase
Chronic Hepatitis C
HIV Infections
Drug: Peginterferon alfa-2a
Phase IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C
Drug Information available for: Peginterferon Alfa-2a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: Treatment of Patients With Chronic Hepatitis C co-Infected With HIV Relapsers After Treatment With Previous Therapies: Open, Pilot Trial

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:
  • 1.- % of patients with RNa-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy. 2.- Ribavirin levels 3.- Impact of dose reduction peg-interferon and/or ribavirin. [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ]

Estimated Enrollment: 150
Study Start Date: March 2006
Estimated Study Completion Date: December 2008
Intervention Details:
    Drug: Peginterferon alfa-2a
    180 mcg/week
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530972

Contacts
Contact: Vicente Soriano, Dr +34914532536 vsoriano@dragonet.es
Contact: Pablo Barreiro, Dr +34914532500 pbarreiro@v4066.drago.net

Locations
Spain, Madrid
Hospital Carlos III Recruiting
Madrid., Madrid, Spain, 28029
Contact: Vicente Soriano, Dr     +34914532536     vsoriano@dragonet.es    
Contact: Pablo Barreiro, Dr     +34914532500     pbarreiro@v4066.drago.net    
Principal Investigator: Vicente Soriano, Dr            
Sub-Investigator: Pablo Barreiro, Dr            
Sub-Investigator: Pablo Labarga, Dr            
Sub-Investigator: Luz Martín-Carbonero, Dr            
Sub-Investigator: Javier García-Samaniego, Dr            
Sub-Investigator: Sonia Rodríguez-Novoa, Dr            
Sub-Investigator: Eugenia Vispo, Dr            
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Principal Investigator: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
  More Information

Study ID Numbers: 2005-001192-34
Study First Received: September 17, 2007
Last Updated: October 2, 2007
ClinicalTrials.gov Identifier: NCT00530972  
Health Authority: Spain: Spanish Agency of Medicines

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Liver Diseases
Hepatitis, Chronic
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Flaviviridae Infections
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009