Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

  • STATUS
    Recruiting
  • End date
    Jul 1, 2021
  • participants needed
    90
  • sponsor
    University of Maryland, Baltimore
Updated on 16 December 2019
Investigator
Rachel Silk, RN
Primary Contact
Unity Parkside Health Center (4.2 mi away) Contact
+1 other location
hepatitis
ribavirin
mono
hcv genotype
grazoprevir
elbasvir
hepatitis c antibody
mononucleosis
zepatier

Summary

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

Details
Treatment Cardiac MRI, Elbasvir / Grazoprevir Oral Tablet [Zepatier]
Clinical Study IdentifierNCT03823911
SponsorUniversity of Maryland, Baltimore
Last Modified on16 December 2019

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: HIV or AIDS Vaccines or HIV infection or HIV positive or Cardiovascular Disease or Hepatitis C virus or Hepatitis C?
Age > or equal to 18 years old
Able and willing to sign informed consent
Chronically infected with any HCV genotype (1a, 1b, 2, 3, 4, 5, or 6), defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)
If HIV+, suppressed on a stable, protocol-approved, ARV regimen for 8 weeks prior to starting HCV treatment
HIV RNA < 50 copies/mL (or < LLOQ if the local laboratory assay's LLOQ is 50 copies/mL) prior to Screening. Subjects with an isolated or unconfirmed HIV RNA > 50 copies/mL (or > LLOQ if the local laboratory assay's LLOQ is 50 copies/mL) are not excluded
CD4 count >100 cells/mm3
Willing to have samples stored for future use
If tested positive for NS5A resistance-associated polymorphisms or PEG-IFN and ribavirin experienced, able to tolerate ribavirin-containing regimen for 16 weeks. Ribavirin will be administered at the discretion of the PI
Women of childbearing potential who receive ribavirin will have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin. Men receiving ribavirin who are sexually active with women will also have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin

Exclusion Criteria

Decompensated liver disease (Childs Pugh B or C)
Unable to comply with research study visits
Poor venous access not allowing screening laboratory collection
Have any condition that the investigator considers a contraindication to study participation
Pregnant or breastfeeding woman
Prior HCV treatment with Direct-Acting Antivirals. Note: Patients who are treatment-experienced with PEG-IFN/RBV will not be excluded; their inclusion in the study will be considered by the PI
HIV+ patients with prior HCV treatment who achieved sustained virologic response (SVR)/ functional cure
Use of a concomitant medication that is contraindicated with the use of the DAA for HCV treatment (per package insert)
Coinfection with HCV and HBV, in partcular HBsAg + patients
Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI
Have any condition that the investigator considers a contraindication to study participation or not eligible per standard of care for HCV treatment
Patients with the following devices are excluded from participating in the cardiovascular MRI study
Central nervous system aneurysm clip
Implanted neural stimulator
Implanted cardiac pacemaker or defibrillator
Cochlear implant
Ocular foreign body (e.g. metal shavings)
Implanted insulin pump
Metal shrapnel or bullet
The following groups of people are also excluded from participating in the cardiovascular MRI study
Patients with stable renal disease (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2 body surface area. The eGFR must be within two weeks of the the MRI exam
Patients with acute renal disease
Patients who choose to have the cardiac MRI and are over 60 years of age, have a history of renal failure, or have type I or II diabetes mellitus must have laboratory tests the same day as the MRI exam
Positive urine drug screen at screening. Not all patients with positive drug screen will be excluded; decision will be made by the PI
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet