Clinical trial NCT00530972: Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
HIV Infections
Keywords: co-infected HCV/HIV
relapsers
Lead sponsor: Hospital Carlos III, Madrid
Sponsor class: OTHER
First posted: 2007-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % of patients with RNA-HCV undetectable
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: % of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy
timeFrame: At weeks 4, 12, 24 and 48 on treatment
measure: Ribavirin levels
timeFrame: At weeks 4, 12, 24 and 48 on treatment
measure: Impact of dose reduction peg-interferon and/or ribavirin
timeFrame: At weeks 4, 12, 24 and 48 on treatment
Other outcomes:
Locations:
city: Madrid.
country: Spain
facility: Hospital Carlos III
state: Madrid
Study officials:
affiliation: Hospital Carlos III. Madrid. Spain
name: Vicente Soriano, Dr
role: PRINCIPAL_INVESTIGATOR
References: