Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Diane V. Havlir

Description

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.

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

Keywords

Hepatitis C HIV-1-infection Liver Diseases Infection Communicable Diseases Sofosbuvir Sofosbuvir-velpatasvir drug combination Epclusa

Eligibility

You can join if…

Open to people ages 18 years and up

(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:
  • 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:
  • 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

  1. If a participant is HIV-infected AND not taking ART, absolute CD4+ count must be >350 cells/µl.
  2. 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:
  3. Albumin >3.0 g/L
  4. Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men
  5. Platelet count >50,000/mm3
  6. Calculated creatinine clearance (CrCl) using Cockcroft-Gault method >30 mL/min
  7. Aspartate aminotransferase (AST/SGOT) <10 times the upper limit of the normal range (ULN)
  8. Alanine aminotransferase (ALT/SGPT) <10 times the ULN
  9. Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV) and<3 times the ULN for participants on ATV
  10. International normalized ratio (INR) <1.5 times the ULN
  11. 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.
  12. 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.
  13. 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.

You CAN'T join if...

(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.

Locations

  • Ucsf Aids Crs (801) accepting new patients
    San Francisco California 94110 United States
  • UCLA CARE Center CRS (601) accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Clinical Trials Group
ID
NCT03512210
Phase
Phase 4
Lead Scientist
Diane V. Havlir
Study Type
Interventional
Last Updated