An Efficacy and Safety Study of MK-5172 + MK-8742 in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus (C-EDGE COINFECTION) (MK-5172-061)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02105662
First received: April 2, 2014
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of MK-5172 100 mg in combination with MK-8742 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive MK-5172 + MK-8742 and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.


Condition Intervention Phase
Chronic Hepatitis C
Drug: MK-5172 100 mg/MK-8742 50 mg fixed-dose combination tablets
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, GT5, and GT6 Infection Who Are Co-Infected With HIV

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) [ Time Frame: Follow-up Week 12 (Up to 24 weeks) ] [ Designated as safety issue: No ]
  • Percentage of participants experiencing adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants discontinuing study drug due to adverse events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24) [ Time Frame: Follow-up Week 24 (Up to 36 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5172+MK-8742
Participants receive MK-5172 100 mg + MK-8742 50 mg fixed-dose combination tablets, orally once daily for 12 weeks.
Drug: MK-5172 100 mg/MK-8742 50 mg fixed-dose combination tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented chronic HCV genotype (GT) 1, GT4, GT5, or GT6 infection with no evidence of non-typeable or mixed GT infection
  • Treatment naïve for all anti-HCV treatments
  • HIV-1 infection documented by laboratory test
  • Currently naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART during this study OR on a HIV ART for at least 8 weeks prior to study entry
  • Has not experienced any alteration(s) in HIV therapy within 4 weeks of randomization
  • Has at least one viable antiretroviral regimen alternative beyond the current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance
  • Participants of reproductive potential must agree to remain abstinent from heterosexual activity OR use (or have their partner use) acceptable contraception during heterosexual activity while receiving study drug and for 14 days after last dose of study drug.

Exclusion Criteria:

  • Evidence of decompensated liver disease manifested by the presence or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs of symptoms of advanced liver disease
  • Co-infected with hepatitis B virus
  • History of malignancy <=5 years prior to study start except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or is under evaluation for other active or suspected malignancy
  • Taking or planning to take any HIV therapy that includes a ritonavir-boosted or unboosted protease inhibitor, efavirenz or etravirine
  • Currently participating or has participated in a study with an investigational compound within 30 days of study start and is not willing to refrain from participating in another study during this study
  • Clinically-relevant drug or alcohol abuse within 12 months of study start
  • Pregnant, breast feeding, or expecting to conceive or donate eggs from Day 1 of the study throughout treatment and 14 days after the last dose of study medication, or longer if dictated by local regulations
  • Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
  • Poor venous access
  • History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
  • Medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during this study
  • History of opportunistic infection in the 6 months prior to study start
  • Use of HIV drugs other than a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitibine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine)
  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: NCT02105662

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 24 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02105662     History of Changes
Other Study ID Numbers: 5172-061, 2014-000342-30
Study First Received: April 2, 2014
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 26, 2014