MK-5172/MK-8742 in HCV Subjects on Opiate Substitution Therapy.
- Conditions
- Hepatitis CMedDRA version: 17.0 Level: LLT Classification code 10019183 Term: HCV System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000343-32-GB
- Lead Sponsor
- Merck Sharp & Dohme Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
In order to be eligible for participation in this trial, the subject must:
•Be greater than or equal to 18 years of age.
•Test positive for HCV infection (as measured by RNA).
•Have chronic genotype 1, 4, 5, or 6 Hepatitis C virus.
•Be on opiate substitution therapy (OST), have kept at least 80% of scheduled appointments while on OST, and not missed any scheduled appointments between screening and study entry.
•Have had a liver biopsy, Fibroscan, or Fibrotest to check for extent of liver disease and/or cirrhosis or to determine absence of cirrhosis.
•Be treatment naïve to all HCV treatment
•May be coinfected with HIV1. If positive for HIV-1 co-infection, then subject must be either treatment naïve to any antiretroviral therapy (ART) or have been stable on ART for at least 8 weeks and have no plans to change therapy during the course of the study. ART permitted on the study is a dual NRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirnine). Participants with HIV infection on ART must have a CD4 T-cell count of more than 200 cells/mm3 and have undetectable plasma HIV-1.Participants with HIV infection but naive to ART must have a CD4 T-cell count of more than 500 cells/mm3 and have HIV-RNA levels <50,000 copies/mL. HIV infected participants must not have failed more than 1 past HIV treatment regimen.
•Agree to use acceptable methods of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
The subject must be excluded from participating in the trial if the subject:
•Is under the age of legal consent, is mentally ill, is legally incapacitated or has significant emotional or psychiatric problems which may interfere with the study procedures.
•Has signs of decompensated liver disease.
•Is coinfected with Hepatitis B virus.
•Has signs of hepatocellular carcinoma or history of malignancy.
•Is taking or plans to take any medication not allowed for this study.
•Is currently participating or has participated in a study with an investigational compound within the last 30 days
•Is currently using or intends to use barbiturates
•Is pregnant or breastfeeding or plans to conceive or donate eggs
•Has a history of, or signs of, chronic hepatitis not caused by hepatitis C virus.
•Has an exclusionary laboratory value
•Has HIV and uses HIV drugs other than a dual NNRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir [or dolutegravir or rilpivine]
•Has an organ transplants (other than cornea and hair).
•Has poor venous access which may complicate routine peripheral blood sampling
•Has history of gastric surgery or malabsorption disorders
•Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
.Has any condition or laboratory abnormality, or history of any illness, which might complicate the results of the study or pose additional risk in administering the study drugs to the subject.
•Has a history of opportunistic infection
•Is an immediate family member of someone directly involved with this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method