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Clinical Trials

MainTitle

Impact of Hepatitis C Therapy and Bone Health (HCV)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified June 2017 by Dallas VA Medical Center

Sponsor
Dallas VA Medical Center

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Dallas VA Medical Center
ClinicalTrials.gov Identifier
NCT03221582

First received: June 27, 2017
Last updated: July 13, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

Condition Intervention Phase
Human Immunodeficiency Virus
Hepatitis C

Drug : EBR/GZR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of HCV Therapy on Cardiovascular Risk and Bone Health

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures

  • Evaluate the impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients and HIV/HCV co-infected patients [ Time Frame: 48 weeks ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, positron emission tomography (PET) scanning for arterial inflammation, coronary calcification and myocardial viability.
Secondary Outcome Measures:
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 0 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients. [ Time Frame: Bone mineral density measured at week 0 of therapy ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 12 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 24 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients. [ Time Frame: Bone mineral density measured at week 48 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 0 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients. [ Time Frame: Bone mineral density measured at week 0 of therapy ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 12 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 24 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
  • Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients. [ Time Frame: Biomarkers of inflammation and bone turnover measured at week 48 of therapy. ]
    Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).

Estimated Enrollment: 60
Study Start Date: July 2017
Estimated Study Completion Date: December 1, 2019
Estimated Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: EBR/GZR (Zepatier) - HCV/HIV co-infected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Drug: EBR/GZR

Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.

Other Name: Zepatier
Experimental: EBR/GZR (Zepatier) - HCV monoinfected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Drug: EBR/GZR

Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.

Other Name: Zepatier

Detailed Description:

Both HCV and HIV are associated with an increased risk of osteoporosis and osteoporotic fractures among HIV-infected patients and the general population. While HIV significantly increases cardiovascular risk, the contribution of HCV to cardiovascular disease (CVD) is less certain. Increased inflammation could potentially underlie the effect of HCV on CVD, bone health, and other extra-hepatic complications. HCV appears to remain an independent predictor of osteoporotic fractures even after controlling for severity of liver disease. The impact of HCV therapy on inflammation, CVD and bone health is unclear. Our previous studies suggest a beneficial impact of interferon therapy on bone turnover and some CVD markers, while others studies have found on-treatment increases in bone mineral density with interferon-based therapy. Whether these are related to the interferon itself or the virologic response, and whether changes in biomarkers lead to improved fracture risk or CVD morbidity is uncertain. Investigator propose to conduct a prospective analysis of markers of inflammation, immune activation, and bone turnover as well as bone mineral density (BMD) among both HIV/HCV co-infected and HCV mono-infected patients undergoing treatment with the novel direct-acting antiviral elbasvir/grazoprevir (EBR/GZR). Should EBR/GZR therapy significantly improve CV risk and bone health, it would be an additional benefit and indication for its use in HCV therapy.

Eligibility

Eligibility

Ages Eligible for Study: 40 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • HCV antibody and HCV RNA positive
  • HCV genotype 1 or genotype 4
  • No prior HCV therapy
  • HCV/HIV on HAART for at least 6 months, undetectable HIV viremia at study entry


Exclusion Criteria:
  • Hepatitis B surface antigen positivity
  • HIV patients with concomitant treatment with tenofovir + boosted protease inhibitor
  • HIV patients with glomerular filtration rate <60
  • Decompensated cirrhosis
  • HCV/HCV excluded if have creatinine clearance <60 or receiving a combination of
tenofovir + a boosted protease inhibitor

contacts and locations

Contacts and Locations

Choosing 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: NCT03221582

Contacts

Contact:   Dindi Moore-Matthews, MS 214-857-1415 dindi.moore-matthews@va.gov

Locations

United States, Texas
Dallas VA Medical Center Active, not recruiting
Dallas, Texas, United States, 75216

Sponsors and Collaborators

Dallas VA Medical Center
Merck Sharp & Dohme Corp.

Investigators

Principal Investigator: Roger Bedimo, MD Dallas VAMC
More Information

More Information


Responsible Party: Dallas VA Medical Center  
ClinicalTrials.gov Identifier: NCT03221582   History of Changes  
Other Study ID Numbers: MISP 54850  
Study First Received: June 27, 2017  
Last Updated: July 13, 2017  

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Elbasvir-grazoprevir drug combination

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.