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Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection (MINMON)

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ClinicalTrials.gov Identifier: NCT03512210
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Brief Summary:
This study is being done to see if a minimal monitoring approach is effective and safe when providing HCV treatment. The minimal monitoring approach will require fewer study visits and lab tests with no medication refills. This study is trying to see whether taking an HCV treatment with fewer clinic visits and laboratory tests can cure just as many people as the standard approach that uses more visits and laboratory tests. The results of this study will be compared with what has been observed in other studies using a standard approach.

Condition or disease Intervention/treatment Phase
Hepatitis C HIV-1-infection Liver Diseases Drug: Epclusa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Oral fixed dose combination sofosbuvir/velpatasvir
Participants will receive fixed dose combination (FDC) sofosbuvir/velpatasvir (SOF/VEL) [Tradename: Epclusa] (400mg/100mg) orally once daily with or without food.
Drug: Epclusa
Sofosbuvir/Velpatasvir contains 400 mg of SOF and 100mg of VEL
Other Name: Sofosbuvir/Velpatasvir




Primary Outcome Measures :
  1. Sustained virologic response (SVR) [ Time Frame: From 22 to 76 weeks ]
    Sustained virologic response defined as <LLOQ of HCV RNA in plasma from the earliest sample drawn at least 22 weeks following study entry. Missing results will be treated as SVR non-responders.

  2. Safety Adverse Events (SAEs) [ Time Frame: 24 weeks ]
    SAEs as defined by International Council for Harmonization (ICH) guidelines.


Secondary Outcome Measures :
  1. Number of participants with at least one unplanned clinic visit prior to SVR evaluation [ Time Frame: Measured through Week 24 ]
  2. Number of participants with reportable adverse events (AEs) not qualifying as SAEs [ Time Frame: Measured through Week 24 ]
    Reportable AEs include all grade ≥ 3 Adverse Events, and all AEs that led to a change in study treatment regardless of grade

  3. Number of participants who discontinue HCV study medications prematurely as defined by self-report by study participant [ Time Frame: Measured through Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Step 1):

  • Ability and willingness of participant to provide informed consent.
  • Active HCV infection confirmed by a detectable HCV RNA by PCR (HCV RNA >1000 international units (IU)/ml) within 35 days prior to study entry. HCV RNA must be obtained by any FDA-approved test for quantifying HCV RNA at any local laboratory that has a CLIA certification, its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs. NOTE: HCV NRA can be obtained at screening visit.
  • HCV treatment naïve defined as not having been previously treated for HCV infection with any medications approved for the treatment of HCV in any country.
  • Liver disease stage defined as non-cirrhotic or compensated cirrhotic (metric/diagnostic criteria used for fibrosis staging) within 35 days prior to study entry as listed below:

A. FIB-4 <3.25 corresponding to no cirrhosis OR B. FIB-4 ≥3.25 AND Child-Turcotte-Pugh (CTP) Score ≤6 indicating CTP Class A corresponding to compensated cirrhotic.

  • HIV-1 infection status documented as either absent or present, as defined below:

Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 60 days prior to entry.

OR

HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.

NOTE: The term "licensed" refers to a US FDA-approved kit, which is recommended. For sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within the country and validated internally is acceptable.

WHO and CDC (US Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

  • For HIV co-infected participants, HIV-1 RNA obtained within 90 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
  • HIV co-infected participants must satisfy one of the two criteria listed below:

A. If a participant is HIV-infected and is taking ART then, plasma HIV RNA <400 copies/mL based on criteria listed in protocol AND current ARV regimen does not include efavirenz (EFV) AND no exposure to EFV ≤14 days prior to study entry. Any absolute CD4+ count is acceptable if this HIV RNA criterion is met.

NOTE: Any participant on an EFV containing ART regimen during the screening period must be switched off EFV and have another regimen, excluding EFV, started at least 14 days prior to study entry.

OR

B. If a participant is HIV-infected AND not taking ART, absolute CD4+ count must be >350 cells/µl.

  • The following laboratory values obtained within 35 days prior to entry by any US laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:

    • Albumin >3.0 g/L
    • Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men
    • Platelet count >50,000/mm3
    • Calculated creatinine clearance (CrCl) using Cockcroft-Gault method >30 mL/min
    • Aspartate aminotransferase (AST/SGOT) <10 times the upper limit of the normal range (ULN)
    • Alanine aminotransferase (ALT/SGPT) <10 times the ULN
    • Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV) and <3 times the ULN for participants on ATV
    • International normalized ratio (INR) <1.5 times the ULN
  • Female participants of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, i.e., 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 or urine pregnancy test within 48 hours prior to study entry by any laboratory or clinic that has a CLIA certificate or its equivalent, or is using a point-of-care (POC)/CLIA-waived test. The serum, urine or POC pregnancy test must have a sensitivity of at least 25 mIU/mL.
  • All participants of reproductive potential must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donate, in vitro fertilization,) while on study treatment and for 6 weeks after stopping protocol-specified medication.
  • When participating in sexual activity that could lead to pregnancy, all participants of reproductive potential must agree to use at least one reliable form of contraceptive while receiving protocol-specified medication, and for 6 weeks after stopping the medication. Such methods include: Condoms (either self or require their partner to use one) with or without a spermicidal agent; Diaphragm or cervical cap with or without spermicidal agent; Intrauterine device (IUD); Hormone-based contraceptive; Tubal ligation.

NOTE: Providers and participants should be advised that not all contraceptive choices listed above can prevent HIV transmission and that some may actually increase the risk of HIV acquisition. Study participants who are sexually active with HIV-1 negative or unknown HIV-1 serostatus partners should be advised that they need to consider effective strategies for reducing the risk of HIV transmission, as well as meeting the requirement for effective contraception during their participation in the study. Study participants should discuss contraceptive choices and HIV risk reduction methods with their health care provider.

  • Participants 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 below. Male participants do not need to provide information on their female partner's reproductive potential.

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.

    • Life expectancy >12 months, in the opinion of the site investigator.
    • Willingness and ability to be contacted remotely via telephone, text message, email, social media applications or any other modality.

Inclusion Criteria (Step 2):

  • Completion of SVR evaluation visit in Step 1.

Exclusion Criteria (Step 1):

  • Positive for the presence of hepatitis B virus (HBV) surface antigen (HBsAg).
  • For cirrhotic participants, CTP score >6 corresponding to Class B or C.
  • Breastfeeding or pregnancy.
  • Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
  • Active drug or alcohol use or dependence and other conditions that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Acute or serious illness requiring systemic treatment and/or hospitalization within 35 days prior to study entry.
  • In HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 35 days prior to study entry. NOTE: AIDS-defining opportunistic infections as defined by the CDC found in the following document: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
  • Any history of hepatic decompensation including ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, and/or bleeding esophageal varices prior to study entry.
  • Use of prohibited medications within the past 14 days prior to study entry.

There are no exclusion criteria for Step 2.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512210


Locations
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United States, Alabama
31788 Alabama CRS Recruiting
Birmingham, Alabama, United States, 35294
Contact: Pamela Cunningham, RN, BSN, MPH    205-996-2373    pamelacunningham@uabmc.edu   
Principal Investigator: Michael Saag, MD         
United States, California
University of Southern California (1201) Recruiting
Los Angeles, California, United States, 90033-1079
Contact: Luis M Mendez    323-343-8283    lmendez@usc.edu   
Principal Investigator: Fred Sattler, MD         
UCLA CARE Center CRS (601) Recruiting
Los Angeles, California, United States, 90095
Contact: Arezou Akha    310-557-3798    asadighi@mednet.ucla.edudu   
Principal Investigator: Raphael Landovitz, MD         
Ucsd, Avrc Crs (701) Recruiting
San Diego, California, United States, 92103
Contact: Jill Kunkel    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Constance A. Benson, MD         
Ucsf Aids Crs (801) Recruiting
San Francisco, California, United States, 94110
Contact: Jay Dwyer, RN, ACRN    415-476-4082 ext 353    jdwyer@php.ucsf.edu   
Principal Investigator: Diane V. Havlir, MD         
United States, Colorado
University of Colorado Hospital CRS (6101) Recruiting
Aurora, Colorado, United States, 80045
Contact: Suzanne G Fiorillo, MSPH    303-724-5931    suzanne.fiorillo@ucdenver.edu   
Principal Investigator: Thomas B Campbell, MD         
United States, Georgia
The Ponce de Leon Center CRS Recruiting
Atlanta, Georgia, United States, 30308
Contact: Ericka Patrick    404-616-6313    erpatri@emory.edu   
Principal Investigator: Carlos Del Rio         
United States, Illinois
Rush Univ. Med. Ctr. ACTG CRS (2702) Recruiting
Chicago, Illinois, United States, 60612
Contact: Antoinette Lewis    312-942-2050    antoinette_lewis@rush.edu   
Principal Investigator: Beverly E Sha, MD         
United States, Maryland
201 Johns Hopkins University CRS Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ilene Wiggins, RN    410-955-8571    iwiggin1@jhmi.edu   
Principal Investigator: Yukari C Manabe, MD         
United States, Massachusetts
101 Massachusetts General Hospital (MGH) CRS Recruiting
Boston, Massachusetts, United States, 02114
Contact: Teri Flynn, RN, ANP, MSN    617-724-0072    tflynn@partners.org   
Principal Investigator: Rajesh Gandhi, MD         
107 Brigham and Women's Hosp. ACTG CRS Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cheryl Keenan, RN    617-732-5635    Ckennan@BWH.Harvard.edu   
Contact    617-732-5635    Ckennan@BWH.Harvard.edu   
Principal Investigator: Paul E. Sax, MD         
United States, Missouri
Washington U CRS (2101) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michael Klebert, RN,C, PhD, ANP    1-314-747-1098    mklebert@im.wustl.edu   
Principal Investigator: Rachel Presti, MD, PhD         
United States, New York
7803 Weill Cornell Upton CRS Recruiting
New York, New York, United States, 10065
Contact: Rebecca Fry, MSN, FNP    212-746-4166    ref2007@med.cornell.edu   
Principal Investigator: Marshall J. Glesby, MD         
United States, North Carolina
Greensboro CRS (3203) Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Kim Epperson, RN, BSN, CCRC    336-832-7888    kim.epperson@mosecone.com   
Principal Investigator: Cornelius Van Dam, MD         
United States, Ohio
Univ. of Cincinnati CRS (2401) Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Sharon Kohrs, RN, BSN    513-584-6383    kohrssd@ucmail.uc.edu   
Principal Investigator: Carl Fichtenbaum, MD         
Case CRS (2501) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jane Baum, RN    216-844-2546    baum.jane@clevelandactu.org   
Principal Investigator: Benigno Rodriguez, MD         
The Ohio State Univ. AIDS CRS (2301) Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathy Watson, RN    614-293-5856    kathy.watson@osumc.edu   
Principal Investigator: Susan Koletar, MD         
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS (6201) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eileen Donaghy, BSN, CRNP    215-349-8092    eileen.donaghy2@uphs.upenn.edu   
Principal Investigator: Pablo Tebas, MD         
Pittsburgh CRS (1001) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Patricia Peters    412-383-1675    pep1@pitt.edu   
Principal Investigator: Sharon Riddler, MD, MPH         
United States, Texas
Houston AIDS Research Team CRS (31473) Recruiting
Houston, Texas, United States, 77030
Contact: Maria Martinez, BS    713-500-6718    maria.l.martinez@uth.tmc.edu   
Principal Investigator: Roberto Arduino, MD         
Puerto Rico
Puerto Rico-AIDS CRS (5401) Recruiting
San Juan, Puerto Rico, 00931
Contact: Sylvia Davila, BS, MS    (787) 767-9192    sylvia.davila@upr.edu   
Principal Investigator: Jorge Santana, MD         
Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Sunil Solomon, MBBS, PhD, MPH Johns Hopkins University

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Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT03512210     History of Changes
Other Study ID Numbers: ACTG A5360
UM1AI068636 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Viral, Human
Hepatitis
Infection
Communicable Diseases
Liver Diseases
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Digestive System Diseases
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents