Treatment of Hepatitis C in Hemophilic Patients With HIV (NCT00055341) | Clinical Trial Compass
CompletedPhase 2
Treatment of Hepatitis C in Hemophilic Patients With HIV
United States22 participantsStarted 2002-03
Plain-language summary
Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.
Who can participate
Age range15 Years
SexALL
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Inclusion Criteria
* Hemophilia A or B
* Exposure to blood or blood products prior to 1987
* Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)"
* HCV reactive by second/third generation ELISA assay and/or RIBA
* HCV RNA positive (PCR or bDNA methods)
* Chronic hepatitis confirmed by liver biopsy within 6 months prior to study entry (Note: cirrhosis is not an exclusion factor)
* HIV infection for coinfected group; HIV viral load of 10,000 copies/ml or less
* If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry
* Acceptable methods of contraception
Exclusion Criteria
* Hemoglobin less than 10 g/dl
* For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit
* Previous interferon or ribavirin therapy
* Corticosteroids or immunomodulatory drugs within 3 months prior to study entry
* Hepatitis B (HBsAg reactive)
* Alpha-1 antitrypsin deficiency
* Wilson's disease
* Hemochromatosis
* Autoimmune disorder
* Decompensated liver disease evidenced by encephalopathy, ascites, or variceal bleed
* Prothrombin Time greater than 3 seconds above normal (International Normalized Ratio \[INR\] greater than 1.3)
* Platelet count less than 90,000/microL
* Active thyroid disease (thyroid replacement with normal TSH permitted)
* Chronic renal insufficiency, defined as creatinine greater than 1.5 mg/dl
* Life-threatening disease processes that could preclude completion of trial
* Alcohol abuse that the local inve…
Trial details
NCT IDNCT00055341
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)