Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection (MINMON)
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
AIDS Clinical Trials Group
First received: April 19, 2018
Last updated: March 4, 2020
Last Verified: March 2020
History of Changes
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.
Drug : Epclusa
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|
Further study details as provided by AIDS Clinical Trials Group:
Primary Outcome Measures
Sustained virologic response (SVR)
[ Time Frame: From 22 to 76 weeks ]
Sustained virologic response defined as
- Safety Adverse Events (SAEs) [ Time Frame: 24 weeks ]
SAEs as defined by International Council for Harmonization (ICH) guidelines.
- Safety Adverse Events (SAEs) [ Time Frame: 24 weeks ]
- Number of participants with at least one unplanned clinic visit prior to SVR evaluation [ Time Frame: Measured through Week 24 ]
- 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
- Number of participants who discontinue HCV study medications prematurely as defined by self-report by study participant [ Time Frame: Measured through Week 12 ]
|Study Start Date:||October 10, 2018|
|Estimated Study Completion Date:||January 4, 2021|
|Estimated Primary Completion Date:||January 4, 2021 (Final data collection date for primary outcome measure)|
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.
Sofosbuvir/Velpatasvir contains 400 mg of SOF and 100mg of VEL
Other Name: Sofosbuvir/Velpatasvir
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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:
- HIV-1 infection status documented as either absent or present, as defined below:
- 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:
- 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.
- 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.
- 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.
- 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.
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.
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.
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.
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.
B. If a participant is HIV-infected AND not taking ART, absolute CD4+ count must be >350 cells/µl.
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.
Written or oral documentation communicated by clinician or clinician's staff of one of the following:
Exclusion Criteria (Step 1):
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03512210
Locations Show More
|United States, Alabama|
|31788 Alabama CRS|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California (1201)|
|Los Angeles, California, United States, 90033-1079|
|UCLA CARE Center CRS (601)|
|Los Angeles, California, United States, 90095|
|Ucsd, Avrc Crs (701)|
|San Diego, California, United States, 92103|
|Ucsf Aids Crs (801)|
|San Francisco, California, United States, 94110|
|United States, Colorado|
|University of Colorado Hospital CRS (6101)|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Whitman Walker Health CRS (31791)|
|Washington, District of Columbia, United States, 20009|
|United States, Georgia|
|The Ponce de Leon Center CRS|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|Northwestern University CRS (2701)|
|Chicago, Illinois, United States, 60611|
|Rush Univ. Med. Ctr. ACTG CRS (2702)|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|201 Johns Hopkins University CRS|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|101 Massachusetts General Hospital (MGH) CRS|
|Boston, Massachusetts, United States, 02114|
|107 Brigham and Women's Hosp. ACTG CRS|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington U CRS (2101)|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|31786 New Jersey Medical School Clinical Research Center CRS|
|Newark, New Jersey, United States, 07103|
|United States, New York|
|Columbia Physicians and Surgeons CRS (30329)|
|New York, New York, United States, 10032|
|7803 Weill Cornell Upton CRS|
|New York, New York, United States, 10065|
|University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Unc Aids Crs (3201)|
|Chapel Hill, North Carolina, United States, 27514|
|Greensboro CRS (3203)|
|Greensboro, North Carolina, United States, 27401|
|United States, Ohio|
|Univ. of Cincinnati CRS (2401)|
|Cincinnati, Ohio, United States, 45267|
|Case CRS (2501)|
|Cleveland, Ohio, United States, 44106|
|The Ohio State Univ. AIDS CRS (2301)|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Hosp. of the Univ. of Pennsylvania CRS (6201)|
|Philadelphia, Pennsylvania, United States, 19104|
|Pittsburgh CRS (1001)|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Rhode Island|
|The Miriam Hospital ACTG CRS (2951)|
|Providence, Rhode Island, United States, 02906|
|United States, Tennessee|
|3652 Vanderbilt Therapeutics (VT) CRS|
|Nashville, Tennessee, United States, 37204|
|United States, Texas|
|31443 Trinity Health and Wellness Center CRS|
|Dallas, Texas, United States, 75208|
|Houston AIDS Research Team CRS (31473)|
|Houston, Texas, United States, 77030|
|Hospital Nossa Senhora da Conceicao CRS (12201)|
|Porto Alegre, RS, Brazil, 9043010|
|Instituto de Pesquisa Clinica Evandro Chagas (12101)|
|Rio de Janeiro, Brazil, 21045|
|Puerto Rico-AIDS CRS (5401)|
|San Juan, Puerto Rico, 00931|
|University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)|
|Johannesburg, Gauteng, South Africa, 2193|
|Family Clinical Research Unit (FAM-CUR) CRS (8950)|
|Cape Town, West Cape, South Africa, 7505|
|Durban Adult HIV CRS (11201)|
|Durban, South Africa, 4013 SF|
|31802 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS|
|Bangkok, Patumwan, Thailand, 10330|
|31784 Chiang Mai University HIV Treatment CRS|
|Chiang Mai, Thailand, 50200|
|Joint Clinical Research Centre (JCRC) (12401)|
Sponsors and CollaboratorsAIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Sunil Solomon, MBBS, PhD, MPH||Johns Hopkins University|
|Responsible Party:||AIDS Clinical Trials Group|
|ClinicalTrials.gov Identifier:||NCT03512210 History of Changes|
|Other Study ID Numbers:||ACTG A5360|
|Study First Received:||April 19, 2018|
|Last Updated:||March 4, 2020|
|Individual Participant Data|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
Sofosbuvir-velpatasvir drug combination
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.