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Treatment of Hepatitis C in Hemophilic Patients with HIV Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Treatment of Hepatitis C in Hemophilic Patients with HIV conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Treatment of Hepatitis C in Hemophilic Patients with HIV Clinical research trials and Treatment of Hepatitis C in Hemophilic Patients with HIV medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Treatment of Hepatitis C in Hemophilic Patients with HIV. Treatment of Hepatitis C in Hemophilic Patients with HIV Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Treatment of Hepatitis C in Hemophilic Patients with HIV clinical trial. Subjects typically recieve the finest healthcare available for their Treatment of Hepatitis C in Hemophilic Patients with HIV condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment of Hepatitis C in Hemophilic Patients with HIV  Treatment of Hepatitis C in Hemophilic Patients with HIV
Treatment of Hepatitis C in Hemophilic Patients with HIV
For Condition: Hepatitis C,Hemophilia,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: Hemophiliacs with symptomatic disease often receive blood products to correct clotting factor deficiencies. Prior to routine use of heat inactivation and screening of donor blood for specific viral pathogens, hemophiliacs were routinely exposed to, and infected with, viruses such as hepatitis B (HBV), HCV, and HIV. Studies in hemophiliacs suggest several important findings that warrant further investigation, including: 1) hemophiliacs infected with HCV may have more rapid progression to liver failure and death; 2) pooled blood concentrate from multiple donors leads to a high risk of mixed infection; and 3) different clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance understanding of mutant virus selection and the associated clinical outcomes. The purpose of this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs with HCV alone and with HCV/HIV coinfection. Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment. Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study. Participants will have 3 additional study visits in the first week of the study. After that, study visits occur at Weeks 2, 4, 8, 12, 16, 24, 32, 40, and 48. The follow-up visits will be at 4, 12, and 24 weeks following the end of treatment. Study visits include a physical exam and blood tests. Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Hemophilia A or hemophilia 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 <= 10,000 copies/ml - If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry - Acceptable methods of contraception Exclusion Criteria - Hemoglobin < 10 g/dl - For HIV coinfected group, CD4 < 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 > 3 seconds above normal (International Normalized Ratio [INR] > 1.3) - Platelet count < 90,000/microL - Active thyroid disease (thyroid replacement with normal TSH permitted) - Chronic renal insufficiency, defined as creatinine >1.5 mg/dl - Life-threatening disease processes that could preclude completion of trial - Alcohol abuse that the local investigator feels would interfere with compliance - Illicit recreational drug use or methadone use within 6 months of study entry - Major depression with hospitalization or suicide attempt is a relative, but not absolute, contraindication to therapy based on timing, circumstances, and current stability as assessed by the investigator - Pregnant or breastfeeding
Total Enrollment: 22
Location and Contact Information:
Overall Study Official:
KennethSherman, Principal Investigator, University of Cincinnati
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Additional Information:
Study ID Numbers: 1R01AI49508-01; 5R01AI049508-02
Study Start Date: March 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055341
Other Hiv Infections Studies:
1. Effects of Ribavirin on Zidovudine or Stavudine
2. Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C with and without Kidney Disease
3. Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis
4. History of Hepatitis C in Volunteer Blood Donors
5. Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Treatment of Hepatitis C in Hemophilic Patients with HIV
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