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Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) Clinical research trials and Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV). Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) clinical trial. Subjects often receive the most expert healthcare possible for their Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)  Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
For Condition: Hepatitis C,HIV Infections,Liver Disease
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study is to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
Details: Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of HCV. This study will test the effectiveness of using PEG-IFN and ribavirin in reducing the rate of liver fibrosis progression in patients coinfected with HIV and HCV who cannot lower their HCV viral load to undetectable or who cannot maintain their HCV viral load at undetectable. Patients will enter Step 1 (also known as Arm A) and will receive 180 mcg PEG-IFN subcutaneously (SQ) once weekly for at least 12 weeks and up to 18 weeks. They will also receive 1 to 1.2 g/day ribavirin based on weight. Patients who have less than a 2-log drop in HCV viral load and have HCV RNA detectable in their blood will enter into Step 2. Those who tolerated Step 1 therapy and have a 2-log or more drop in HCV viral load or have undetectable HCV RNA will enter Step 3. Step 3 patients will continue their Step 1 treatment for an additional 60 weeks and will be followed for 24 weeks after stopping treatment. Patients who enter Step 2 will be randomly assigned to one of two arms. Patients in Arm B will discontinue ribavirin and will receive 180 mcg PEG-IFN SQ once weekly for 72 weeks. Arm C is the observational control arm; patients in Arm C will discontinue both PEG-IFN and ribavirin. Liver biopsies will be conducted at entry to Steps 1 and 2 and at the end of Step 3. Medical history assessment, physical exams, and blood collection will be conducted every 4 weeks for patients in Steps 1, 2, and 3. Patients in Step 2 will be followed for a maximum of 90 weeks. Patients in Step 3 will be followed for a maximum of 96 weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Active Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Step 1: - HIV infected - Stable antiretroviral therapy for at least 8 weeks prior to study entry OR have not received any antiretroviral therapy for at least 4 weeks prior to entry - HIV viral load less than 50,000 copies/ml within 6 weeks prior to study entry - CD4 count greater than 200 cells/mm3 within 6 weeks prior to study entry - Hepatitis C virus (HCV) infected - Either HCV treatment naive OR previously treated with interferon (IFN), PEG-IFN, IFN and ribavirin, or PEG-IFN and ribavirin for at least 12 weeks and are HCV RNA positive following their last course of HCV treatment - Chronic liver disease consistent with chronic viral hepatitis - At least stage I fibrosis on a liver biopsy obtained within 104 weeks of study entry - If at stage VI fibrosis, CPT score of 5 or less and no more than Child-Pugh Class A - Liver enzyme (ALT, AST, and alkaline phosphatase) levels 10 times or less than upper limit of normal - Agree to use acceptable methods of contraception Exclusion Criteria for Step 1: - Have received HCV treatment within 4 weeks of study entry. Patients currently receiving treatment for HCV should be considered for entry into Step 2. - Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry - Alpha feto protein level 400 ng/ml or greater within 24 weeks prior to study entry, or alpha feto protein level greater than 50 ng/ml and less than 400 ng/ml (unless CT scan or MRI shows no evidence of hepatic tumor) within 24 weeks prior to study entry - Decompensated liver disease, including presence or history of ascites, variceal bleeding, and brain or nervous system damage as a result of liver damage - Other causes of significant liver disease, including hepatitis A or B, excess iron deposits in the liver (hemochromatosis), or homozygote alpha-1 antitrypsin deficiency - Use of systemic corticosteroids, interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 2 weeks prior to study entry - Known allergy/sensitivity to PEG-IFN alfa-2a or ribavirin or their formulations - History of uncontrolled seizure disorders - Clinically active thyroid disease. Thyroid hormone replacement therapy is permitted, but TSH and FTI must be in normal range. - History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that may be made worse by interferon use - Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry - Malignancy - Active coronary artery disease within 24 weeks prior to study entry - Acute or active opportunistic infections within 12 weeks of study entry - Hemoglobin abnormalities (e.g., thalassemia) or any other cause of or tendency to break down red blood cells (hemolysis) - History of major organ transplantation with an existing functional graft - Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence - Uncontrolled or active depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, medically untreatable Grade 3 disorder, or any hospitalization within 52 weeks of study entry that, in the opinion of the investigator, may interfere with study requirements - Other serious illness or chronic medical condition that, in the opinion of the investigator, may prevent patient's completion of the study - Pregnant or breastfeeding
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
KennethSherman, Study Chair, University of Cincinnati
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
United States
Christine Tripoli 412-647-0771
University of Texas, Southwestern Medical Center
Dallas, Texas, 75235-9173
United States
Chip Lohner 214-590-0414
Wishard Hospital
Indianapolis, Indiana, 46202
United States
Scott Hamilton 317-630-6023
The Cornell Clinic
New York City, New York, 10021
United States
Valery Hughes 212-746-4393
Rhode Island Hospital
Providence, Rhode Island, 02906
United States
Joan Gormley 401-793-4396
University of Rochester Medical Center
Rochester, New York, 14642-0001
United States
Carol Greisberger 585-275-2740
Johns Hopkins University
Baltimore, Maryland, 21287-8106
United States
Ilene Wiggins 410-614-2766
Stanford University
Stanford, California, 94305-5107
United States
Debbie Slamowitz 650-723-2804
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, 02114
United States
Teri Flynn 617-724-0072
NYU/Bellevue
New York City, New York, 10016-6481
United States
Maura Laverty 212-263-6565
University of Alabama at Birmingham
Birmingham, Alabama, 35924-2050
United States
Karen Savage 205-975-7925
Santa Clara Valley Medical Center
Stanford, California, 94305-5107
United States
Debbie Slamowitz 650-723-2804
University of Cincinnati
Cincinnati, Ohio, 45267-0405
United States
Tammy Powell 513-584-8373
Indiana University Hospital
Indianapolis, Indiana, 46202-5250
United States
Beth Zwickl 317-274-8456
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-5250
United States
Beth Zwickl 317-274-8456
University of Hawaii
Honolulu, Hawaii, 96816-2396
United States
Debra Ogata-Arakaki 808-737-2751
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
United States
Ann Conrad 216-778-5489
University of Texas. Galveston
Galveston, Texas, 77555-0435
United States
Carrie Derkowski 409-747-0241
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
United States
Joan Gormley 401-793-4396
Boston Medical Center (Harvard)
Boston, Massachusetts, 02118
United States
Betsy Adams 617-414-7082
Chelsea Clinic
New York City, New York, 10011
United States
Todd Stroberg 212-746-7198
The Miriam Hospital
Providence, Rhode Island, 02906
United States
Joan Gormley 401-793-4396
Community Health Network, Inc.
Rochester, New York, 14642-0001
United States
Carol Greisberger 585-275-2740
Additional Information:
Study ID Numbers: ACTG A5178; SLAM-C
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078403
Other Hepatitis C Studies:
1. Oxaliplatin to Treat Advanced Cancers With Liver Dysfunction
2. Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
3. Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant
4. Magnetic Resonance Imaging of Blood Flow in the Liver and Abdomen
5. Gabapentin to treat itch in patients with liver disease
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Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
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