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Fw: NATAP: Peg/RBV + HAART ACTG Study

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  • Alley Pat
    NATAP http://natap.org/ ... ACTG Study 5184 Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults This study is currently
    Message 1 of 1 , Jun 16, 2006
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      ACTG Study 5184

      Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults

      This study is currently recruiting patients.

      Purpose
      A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV).

      Hypothesis: In HCV/HIV coinfected patients with CD4 counts of 300 cells/mm3 or greater, initial HIV therapy followed by concurrent HIV and HCV therapy will result in higher early HCV virologic response rates and therefore ultimately higher sustained HCV virologic response rates compared to HCV therapy without HIV therapy.

      Official Title:Â An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin

      Primary Outcomes:Â HCV viral load at least 2 log10 less than baseline or below the limit of detection by quantitative assay at 12 weeks after the start of HCV treatment (early virologic response); HIV and/or HCV treatment-limiting or Grade 4 or higher signs and symptoms and laboratory values

      Expected Total Enrollment:Â 204

      An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One infection often accelerates the progression of the other, and effective management strategies for both infections need to be developed for HCV/HIV coinfected patients. This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone.

      This study will last up to 102 weeks. Participants will be randomly assigned to one of two arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.

      Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in Arm B will be followed for an additional 48 weeks with no treatment.

      There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all visits, and urine collection will occur at selected visits. Participants will also be asked to complete adherence questionnaires. Participants in this study are encouraged to also enroll in ACTG A5128.

      Eligibility

      Inclusion Criteria for Step 1:
      â?¢ HIV infected
      â?¢ HIV viral load of greater than 1000 copies/ml within 45 days of study entry
      â?¢ HCV genotype 1 infected
      â?¢ CD4 count of 300 cells/mm3 or greater within 45 days prior to study entry
      â?¢ Willing to accept randomly assigned study treatment
      â?¢ Willing to use acceptable forms of contraception during the study and for 6 months after stopping all study medications
      â?¢ Chronic liver disease consistent with chronic viral hepatitis as indicated by liver biopsy within 2 years prior to study entry. Participants with cirrhosis must have a serum alpha-fetoprotein of 100 ng/ml or less and a Child-Pugh score of 6 or higher within 45 days prior to study entry to be eligible for this study.


      Exclusion Criteria for Step 1:
      â?¢ Hepatitis B surface antigen positive within 45 days prior to study entry
      â?¢ HCV genotype other than genotype 1 at any time prior to study entry
      â?¢ Any medical conditions associated with chronic liver disease other than HCV (e.g., genetic hemochromatosis, autoimmune hepatitis)
      â?¢ Prior use of intravenous or subcutaneous interferon for more than 2 weeks total at any time prior to study entry
      â?¢ Known allergy/sensitivity to study drugs or their formulations. Participants who are allergic/sensitive to either EFV or LPV/r, but not both, are not excluded.
      â?¢ Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study. Participants in methadone programs are not excluded, but may require methadone dose changes during the study.
      â?¢ Received ART for more than 7 consecutive days within the 6 months prior to study entry
      â?¢ Received 3TC, TDF, a protease inhibitor, or nonnucleoside reverse transcriptase inhibitor for more than 31 days cumulative therapy at any time prior to study entry
      â?¢ Need to start ART at the time of study entry
      â?¢ Uncontrolled diabetes mellitus within 30 days prior to study entry
      â?¢ Previous suicide attempt or hospitalization for a psychiatric illness within 2 years prior to study entry. Participants with psychiatric disease, especially depression, uncontrolled with medication are not eligible for the study.
      â?¢ Prior or current evidence of immunologically mediated disease (e.g., inflammatory bowel disease, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
      â?¢ Chronic pulmonary disease associated with functional limitation
      â?¢ Severe cardiac disease within 24 weeks prior to study entry
      â?¢ History of severe retinopathy due to diabetes, hypertension, cytomegalovirus, or macular degeneration
      â?¢ History of major organ transplantation
      â?¢ Severe illness, cancer, or other conditions that would interfere with the study
      â?¢ Any systemic antineoplastic or immunomodulatory treatment (except epoetin alfa or granulocyte colony-stimulating factor [G-CSF]) or radiation within 24 weeks of study entry. Participants who anticipate the need to begin such treatment during the study are not eligible.
      â?¢ History of hemoglobinopathy (e.g., thalassemia, sickle cell anemia)
      â?¢ Active gout
      â?¢ Requirement for certain medications
      â?¢ Evidence of decompensated liver disease, such as history or presence of ascites, jaundice, bleeding varices, or hepatic encephalopathy
      â?¢ Has a pregnant partner
      â?¢ Pregnancy or breastfeeding

      Location and Contact Information

      Alabama
            University of Alabama at Birmingham, Birmingham, Alabama, 35924-2050, United States; Recruiting Karen G Savage, BSN  205-975-7925  kgsavage@...Â

      California
            UCLA School of Medicine, Los Angeles, California, 77555-0435, United States; Recruiting Carrie Derkowski, BS  310-825-1301  cderkowski@...Â

            San Francisco General Hospital, San Francisco, California, 94110, United States; Recruiting Michele Downing, RN, BSN  415-514-0550 Ext. 354  mdowning@...Â

            University of California, San Diego Antiviral Research, San Diego, California, 92103, United States; Recruiting Jill Kunkel, RN  619-543-8080  jkunkel@...Â

            University of Southern California, Los Angeles, California, 90033-1079, United States; Recruiting Luis M. Mendez  323-343-8283  lmendez@...Â

      Colorado
            Univ. of Colorado Health Sciences Center, Denver, Denver, Colorado, 80262-3706, United States; Recruiting M. Graham Ray, RN, MSN  303-372-5535  graham.ray@...Â

      Illinois
            Northwestern University, Chicago, Illinois, 60611-3015, United States; Recruiting Baiba Berzins, MPH  312-695-5012  baiba@...Â

      Indiana
            Indiana University Hospital, Indianapolis, Indiana, 46202-5250, United States; Recruiting Beth Zwickl, RN,CS, MSN  317-274-8456  bwzwickl@...Â

            Methodist Hospital of Indiana, Indianapolis, Indiana, 46202-5250, United States; No longer recruiting

            Wishard Hospital, Indianapolis, Indiana, 46202, United States; Recruiting Scott Hamilton, RN  317-630-6023  shamilt2@...Â

      Maryland
            University of Maryland, Institute of Human Virology, Baltimore, Maryland, 21201, United States; Recruiting Sandy Zaremba, RN, CCRC  410-706-1476  zaremba@...Â

            Johns Hopkins University, Baltimore, Maryland, 21287-8106, United States; Recruiting Ilene P Wiggins, RN  410-614-2766  imp@...Â

      Massachusetts
            Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States; Recruiting Neah S Kim, MSN, APRN, FNP  (617) 632-7627  nkim@...Â

            Harvard (Massachusetts General Hospital), Boston, Massachusetts, 02114, United States; Recruiting Teri Flynn, RN, ANP  617-724-0072  tflynn@...Â

            Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States; Recruiting Jon Gothing, RN, BSN  617-732-5635  jgothing@...Â

      Minnesota
            Hennepin County Medical Clinic, Minneapolis, Minnesota, 55415, United States; Recruiting Ellen Kane, RN, BSN  612-347-2690  ellen.m.kane@...Â

      Missouri
            Washington University (St. Louis), St. Louis, Missouri, 63108-2138, United States; Recruiting Michael Klebert, RN-C, MSN  314-454-0058  mklebert@...Â

      New York
            Columbia University, New York, New York, 10032-3784, United States; Recruiting Mykyelle Crawford, RN, BSN  212-305-2665  mc675@...Â

      North Carolina
            University of North Carolina, Chapel Hill, North Carolina, 27514, United States; Recruiting Cheryl J Marcus, RN, BSN  919-843-8761  cjm@...Â

            The Moses H. Cone Memorial Hospital, Greensboro, North Carolina, 27401-4001, United States; Recruiting Kim Epperson, RN  336-832-7888  kim.epperson@...Â

            Wake County Department of Health, Chapel Hill, North Carolina, 27514, United States; Recruiting Cheryl J Marcus, RN, BSN  919-843-8761  cjm@...Â

            Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting Eang U King, BS, CLS(NCA)  919-684-8216  King0062@...Â

      Ohio
            Case Western Reserve University, Cleveland, Ohio, 44106-5083, United States; Recruiting Jane Baum, BSN, RN  216-844-2546  baum.jane@...Â

            University of Cincinnati, Cincinnati, Ohio, 45267-0405, United States; Recruiting Tammy Powell, RN  513-584-8373  powelltm@...Â

            Ohio State University, Columbus, Ohio, 43210, United States; Recruiting Todd L Lusch, BA  614-293-8112  lusch-1@...Â

      Pennsylvania
            Presbyterian Medical Center - Univ. of PA, Philadelphia, Pennsylvania, 19104, United States; Recruiting Joseph Quinn, RN  215-349-8092  joseph.quinn@...Â

            University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania, 19104, United States; Recruiting Joseph Quinn, RN  215-349-8092  joseph.quinn@...Â

            University of Pittsburgh, Pittsburgh, Pennsylvania, 15213-2582, United States; Recruiting Christine Tripoli, BSN, RN  412-647-0771  tripolica@...Â

      Rhode Island
            The Miriam Hospital, Providence, Rhode Island, 02906, United States; Recruiting Joan Gormley, BSN  401-793-4396  jgormley@...Â

            Rhode Island Hospital, Providence, Rhode Island, 02906, United States; No longer recruiting

            Stanley Street Treatment and Resource, Providence, Rhode Island, 02906, United States; No longer recruiting

      Texas
            University of Texas, Galveston, Galveston, Texas, 77555-0435, United States; Recruiting Gerianne Casey, RN  409-747-0219  gecasey@...Â

            University of Texas, Southwestern Medical Center, Dallas, Texas, 75235-9173, United States; Recruiting Chip Lohner, MA  214-590-0414  chip.lohner@...Â

      Puerto Rico
            University of Puerto Rico, San Juan, 00936-5067, Puerto Rico; Recruiting Sylvia I Davila, BS, MS  (787) 759-9595  sdavila@...Â

      Study chairs or principal investigators

      Barbara Gripshover, MD, Study Chair, University Hospitals of Cleveland, Case Western Reserve University  Â
      Mark S. Sulkowski, MD, Study Chair, Viral Hepatitis Center, Johns Hopkins University School of Medicine  Â

      Publications

      Mehta SH, Thomas DL, Torbenson M, Brinkley S, Mirel L, Chaisson RE, Moore RD, Sulkowski MS. The effect of antiretroviral therapy on liver disease among adults with HIV and hepatitis C coinfection. Hepatology. 2004 Dec 23;41(1):123-131 [Epub ahead of print]

      Plosker GL, Keating GM. Peginterferon-alpha-2a (40kD) Plus Ribavirin : A Review of its Use in Hepatitis C Virus and HIV Co-infection. Drugs. 2004;64(24):2823-43.

      Sterling RK, Sulkowski MS. Hepatitis C virus in the setting of HIV or hepatitis B virus coinfection. Semin Liver Dis. 2004;24 Suppl 2:61-8. Review.

      Sulkowski MS, Moore RD, Mehta SH, Chaisson RE, Thomas DL. Hepatitis C and progression of HIV disease. JAMA. 2002 Jul 10;288(2):199-206.

      Sulkowski MS, Thomas DL. Hepatitis C in the HIV-infected patient. Clin Liver Dis. 2003 Feb;7(1):179-94. Review.





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