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A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) Clinical research trials and A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV). A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) clinical trial. Human subjects often get the best healthcare available for their A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV) condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)  A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
For Condition: Hepatitis C,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.
Details: Infection with HCV is common in patients infected with HIV owing to similar routes of transmission. The cellular immunosuppression caused by HIV infection appears to lead to an increased HCV plasma load, more progressive liver disease, and, in patients with chronic hepatitis C, increased mortality. Ribavirin treatment combined with IFN has shown improved sustained virologic response rates over IFN monotherapy. PEG-IFN, a chemically modified formulation of IFN, circulates for a much longer time in the blood than the parent compound. Pharmacokinetic and pharmacodynamic data suggest that PEG-IFN injected weekly would have the potential for superior efficacy as compared with IFN injected 3 times per week. The efficacy and safety profiles of combination therapy with PEG-IFN and ribavirin are not well known. This study will compare combination therapy consisting of PEG-IFN and ribavirin with that of IFN and ribavirin. Patients are stratified according to HCV genotype and CD4 count and viral load, then randomized to either Arm A (IFN plus ribavirin) or Arm B (PEG-IFN plus ribavirin). Patients receive up to 48 weeks of treatment. Virologic response is assessed at Week 24 and a decision to continue or discontinue treatment is made. If a virologic response is shown at Week 24, the patient continues treatment for an additional 24 weeks. If no virologic response is observed, then the histologic response is assessed by a liver biopsy. If biopsy shows a histologic response is present, treatment is continued for 24 weeks. If biopsy shows no histologic response, treatment is discontinued. [AS PER AMENDMENT 07/20/01: Patients with virologic response who discontinue after Week 24 will have liver biopsy at time of discontinuation. Patients with no virologic response continuing study treatment after having a liver biopsy within 2 weeks of Week 24, who also demonstrate histologic response and decide to discontinue after Week 24, are strongly encouraged to have a 2nd liver biopsy at the end of treatment. Patients with no virologic response who discontinue after Week 24 will not have liver biopsy at time of discontinuation.] Physical examinations are done regularly and blood samples collected for routine laboratory tests, confidential genetic testing, and to measure HCV and HIV-1 plasma viral loads. Women able to become pregnant have regular pregnancy tests. All patients are followed for an additional 24 weeks after treatment discontinuation. Patients may enroll in 1 or none of the following substudies: A5091s, Hepatic C Viral Kinetics in Subjects Co-infected with Human Immunodeficiency Virus-1 (HIV-1) and Hepatitis C Virus Genotype 1 (HCV-1); [AS PER AMENDMENT 07/20/01: The following text has been deleted: or A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation] [AS PER AMENDMENT 07/20/01: Substudy A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation is now a stand-alone study.]
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have chronic liver disease consistent with chronic hepatitis C. - Have evidence of hepatitis C within the 48 weeks prior to entry. - Are 18 to 65 years old. - Agree to use 2 barrier methods of birth control during the study and for 6 months after stopping the medications. - Meet 1 of the following sets of guidelines: 1) have a CD4 count of more than 100 cells/mm3 and have a viral load (level of HIV in the blood) of less than 10,000 copies/ml within 35 days prior to study entry, and have taken stable anti-HIV drugs for at least 12 weeks prior to study entry and plan to remain on the same treatment for the first 24 weeks of the study; or 2) have a CD4 count of more than 300 cells/mm3 within 35 days prior to study entry and have not taken any anti-HIV drugs in the 12 weeks prior to entry, and do not plan to start anti-HIV treatment within the first 24 weeks of study entry. Exclusion Criteria Patients will not be eligible for this study if they: - Have a positive test for hepatitis B. - Show evidence of medical conditions associated with long-term liver disease other than HCV. - Have severe mental illness, especially depression, or have been hospitalized for mental illness within the previous 24 weeks. - Are allergic to any of the study products. - Have uncontrolled seizures. - Have had or currently have any immune diseases. - Have lung disease such that function is limited. - Have had evidence of heart disease or certain heart problems within 24 weeks of study entry. - Have severe retinopathy (eye disease). - Have had a major organ transplant and still have the graft. - Have any other severe disease or cancer that would interfere with the study. - Have had anti-cancer or immune-regulating drugs or radiation treatment within 24 weeks of study entry or expect to need such treatment during the study. - Have received rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, hydroxyurea, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 6 weeks of study entry. - Abuse drugs or alcohol. Patients in methadone programs may participate. - Have a blood disorder such as thalassemia. - Have received interferon or oral ribavirin therapy. - Have taken an experimental drug that affects HCV, within 6 weeks of study entry. - Need to use during the study any of the drugs prohibited by the study. - Have had an opportunistic (AIDS-related) infection within 4 weeks of study entry. - Are pregnant or breast-feeding.
Total Enrollment: 132
Location and Contact Information:
Overall Study Official:
RaymondChung, Study Chair, Harvard Massachusetts General Hospital
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York City, New York, 10011
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Univ of Washington
Seattle, Washington, 98104
United States
Willow Clinic
Menlo Park, California, 94025
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
University of California San Francisco
San Francisco, California, 941104206
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Emory University Comp Hemophilia Program
Atlanta, Georgia, 30322
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: ACTG A5071; AACTG A5071,Substudy AACTG A5091s
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008463
Other Hiv Infections Studies:
1. Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
2. The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
3. An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination with QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
5. Ganciclovir Implant Study for Cytomegalovirus Retinitis
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
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