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 range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00055341
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)