Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

Description

People who are recently infected with HCV have a great chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a new drug can replace one of the old drugs to provide a safer, more effective, and better tolerated treatment for new HCV infection. The name of this new drug is sofosbuvir (SOF), and it will replace pegylated-interferon alfa (PEG-IFN, a drug given as a weekly injection under the skin). SOF will be given in combination with ribavirin (RBV), a drug approved by the Food and Drug Administration (FDA). All participants in this study will be monitored while on treatment at weeks 1, 2, 4, 8, and 12. All participants will be evaluated for a sustained virologic response (SVR) (undetectable HCV RNA levels) 1, 2, 4, and 8 (for the 8-week regimen) or 12 (for the 12-week regimen) weeks after starting study treatment. After completing treatment, all participants will be evaluated for a SVR 2, 4, 8, 12, and 24 weeks after the end of treatment.

Study Start Date

April 2014

Estimated Completion Date

November 2016

Interventions

  • Drug: Ribavirin
  • Drug: Sofosbuvir
  • Drug: Ledipasvir/Sofosbuvir

Specialties

  • Internal Medicine: Infectious Disease
  • Infectious Disease: HIV/Immunodeficiency,Hepatitis
  • Pharmacy: Antimicrobials
  • Physician Assistant: Infectious Disease

MeSH Terms

  • HIV Infections
  • Hepatitis
  • Sofosbuvir

Study ID

AIDS Clinical Trials Group -- ACTG A5327

Status

Unknown

Trial ID

NCT02128217

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

50

Sponsor

AIDS Clinical Trials Group

Inclusion Criteria

  • HIV-1 infection
  • A documented confirmation of acute HCV infection within 6 months prior to A5327 entry or HCV reinfection as described in section 4.1.2 of the protocol.
  • HCV RNA confirmed to be detectable >12 weeks after first laboratory evidence of acute HCV and still within the <24 week from first laboratory evidence of acute HCV infection window. First laboratory evidence of infection is defined as date of first elevated liver enzymes or date of first serologic evidence of HCV seroconversion and/or viremia (whichever occurs first).
  • HIV-1 ARV therapy should fall into one of the following criteria: 1. ARV untreated, for example due to (1) lack of indication per provider (CD4 T-cell count >500 cells/mm3) or (2) decision by provider and subject to defer ARV therapy during the study drug dosing period (8 or 12 weeks), or (3) elite controller (CD4+ >200 cells/mm3). OR 2. On a stable, protocol-approved (ddI, d4T, ZDV excluded), ARV regimen for >8 weeks prior to screening with a CD4 T-cell count >200 cells/mm3 and a documented plasma HIV-1 RNA level <50 copies/mL by any laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent ? 8 weeks preceding the A5327 screening visit. HIV-1 RNA levels should be within 1 year of the screening visit. Screening HIV-1 RNA must be < 50 copies/mL as measured by any local laboratory using an FDA-approved assay.
  • Candidates must have the following laboratory parameters within 10-42 days prior to study entry: 1. Hemoglobin ? 12 g/dL for male, ?11 g/dL for female subjects 2. International normalized ratio (INR) ?1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 3. Albumin ? 3 g/dL 4. Creatinine clearance (CrCl) ? 60 mL/min, as calculated by the Cockcroft-Gault equation (refer to section 6.3.5 for calculator utility link)
  • Screening electrocardiogram (ECG) without clinically significant abnormalities as determined by the investigator.
  • Female subjects of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy) must have a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL performed during screening, within 48 hours prior to study entry.
  • All subjects must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). NOTE: Female candidates who are pregnant or breastfeeding are not eligible. A male candidate who has a pregnant female partner is not eligible for the study.
  • When participating in sexual activity that could lead to pregnancy, all subjects must agree to use at least two reliable forms of contraceptive simultaneously while receiving protocol-specified medications, and for 6 months after stopping the medications. Such methods include:
  • Condoms (male or female) with or without a spermicidal agent
  • Diaphragm or cervical cap with spermicide
  • Intrauterine device (IUD)
  • Tubal ligation
  • Hormone-based contraceptive (except those containing drospirenone)
  • Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy or men who have documented azoospermia or undergone vasectomy) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization and menopause is specified as written or oral documentation communicated by clinician or clinician's staff of one of the following:
  • Physician report/letter
  • Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
  • Discharge summary
  • Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory.
  • Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria

  • Received investigational drug or device within 60 days prior to study entry.
  • Prior exposure to a direct-acting antiviral (DAA) targeting the HCV NS5B polymerase. NOTE: DAAs include but are not limited to: mericitabine, ABT-333, ABT-072, BI-207127, BMS-791325, VX-222, tegobuvir, IDX719, setrobuvir, GS-9669, VX-135.
  • Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, ?1 antitrypsin deficiency, primary sclerosing, cholangitis).
  • Presence of active or acute AIDS-defining opportunistic infections within 30 days prior to study entry. NOTE: A list of AIDS-defining opportunistic infections as defined by the CDC, can be found in Appendix B of the following document: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
  • Active, serious infection (other than HIV-1 or HCV) requiring parenteral antibiotics, antivirals, or antifungals within 30 days prior to study entry.
  • Infection with hepatitis B virus (HBV) defined as HBsAg positive.
  • Evidence of acute hepatitis A infection defined as HAV IGM positive.
  • History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia).
  • Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day).
  • History of solid organ transplantation.
  • Current or prior history of clinical hepatic decompensation (eg, ascites, encephalopathy or variceal hemorrhage).
  • History of a gastrointestinal disorder (or post operative condition) that could interfere with the absorption of the study drug.
  • History of significant or symptomatic pulmonary disease, cardiac disease, or porphyria.
  • History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  • History of clinically significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with study requirements, which may include active drug or alcohol use or dependence.
  • Use of any prohibited concomitant medications within 30 days prior to study entry.
  • Known hypersensitivity to RBV, SOF, its metabolites, or formulation excipients or any other contraindication to the use of RBV or SOF.
  • Currently receiving ZDV, ddI, or d4T.
  • Acute HIV infection defined as the phase immediately following infection during which anti-HIV antibodies are undetectable.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (16)

Study Location Distance Name Phone Email
107 Brigham and Womens Hosp ACTG CRS - Boston, Massachusetts 2.6 miles Cheryl Keenan RN 617-732-5635 None
101 Massachusetts General Hospital MGH CRS - Boston, Massachusetts 2.8 miles Teri Flynn RN ANP MSN 617-724-0072 tflynn@partners.org
2951 The Miriam Hospital TMH ACTG CRS - Providence, Rhode Island 39.6 miles Pamela Poethke RN 401-793-4396 ppoethke@lifespan.org
7804 Weill Cornell Chelsea CRS - New York, New York 187.0 miles Todd Stroberg RN BSN 212-746-4177 tstrober@med.cornell.edu
7803 Weill Cornell Upton CRS - New York, New York 187.1 miles Valery Hughes FNP 212-746-4393 vah9001@med.cornell.edu
6201 Penn Therapeutics CRS - Philadelphia, Pennsylvania 270.8 miles Joseph Quinn RN 215-349-8091 joseph.quinn@uphs.upenn.edu
201 Johns Hopkins University CRS - Baltimore, Maryland 356.4 miles Ilene Wiggins RN 410-955-2898 imp@jhmi.edu
3201 Chapel Hill CRS - Chapel Hill, North Carolina 619.9 miles Susan Pedersen RN BSN 919-966-6712 None
2701 Northwestern University CRS - Chicago, Illinois 847.9 miles Baiba Berzins MPH 312-695-5012 baiba@northwestern.edu
5802 The Ponce de Leon Center CRS - Atlanta, Georgia 935.3 miles Ericka Patrick RN MSN 404-616-6313 erpatri@emory.edu
2101 Washington University Therapeutics WT CRS - St. Louis, Missouri 1,039.5 miles Michael Klebert RN PhD CANP 314-454-0058 mklebert@im.wustl.edu
31443 Trinity Health and Wellness Center CRS - Dallas, Texas 1,554.0 miles Michelle Mba MPH 972-807-7370 michelle.mba@aidsarms.org
31473 Houston AIDS Research Team HART CRS - Houston, Texas 1,609.9 miles Maria Martinez BS 713-500-6718 maria.l.martinez@uth.tmc.edu
6101 University of Colorado Hospital CRS - Aurora, Colorado 1,765.3 miles Mary G Ray RN MSN 303-724-0712 graham.ray@uchsc.edu
701 University of California San Diego AntiViral Research Center CRS - San Diego, California 2,582.6 miles Jill Kunkel 619-543-8080 jkunkel@ucsd.edu
801 University of California San Francisco HIVAIDS CRS - San Francisco, California 2,698.0 miles Jay Dwyer RN 415-514-0550 jdwyer@php.ucsf.edu

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