Trial record 19 of 35 for:
" September 12, 2007":" October 12, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies (PILOT-NR)
This study has been completed.
Sponsor:
Hospital Carlos III, Madrid
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT00530972
First received: September 17, 2007
Last updated: September 4, 2009
Last verified: September 2009
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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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Ribavirin levels [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ] [ Designated as safety issue: No ]
- Impact of dose reduction peg-interferon and/or ribavirin [ Time Frame: At weeks 4, 12, 24 and 48 on treatment ] [ Designated as safety issue: No ]
| 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| 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 More Information
No publications provided
| Responsible Party: | Vicente Soriano, Hospital Carlos III |
| ClinicalTrials.gov Identifier: | NCT00530972 History of Changes |
| Other Study ID Numbers: | 2005-001192-34 |
| Study First Received: | September 17, 2007 |
| Last Updated: | September 4, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Carlos III, Madrid:
|
co-infected HCV/HIV relapsers |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013