A Clinical Trial to Study the Safety and Effectiveness of the combined dosage of MK-5172 and MK-8742 with and without Ribavirin in Hepatitis C Infected Patients
- Conditions
- Hepatitis C Virus Genotype 1 (HCV GT 1)MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003354-89-DE
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
In order to be eligible for participation in this trial, the subject must:
1. be =18 years of age on day of signing informed consent.
2. have a body weight =50 kg (111 lbs) and = 125 kg (275 lbs).
3. have chronic, compensated HCV GT1 infection
4. have liver disease staging assessment 5. Have prior Peg-IFN treatment status
6. For HIV coinfected subjects these additional criteria must also be met:
•Be HIV-1 infected, documented by any licensed rapid HIV test or HIV
enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Day 1) 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 p24 antigen, or plasma HIV-1 RNA viral load.
•Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to
study entry using a dual NRTI backbone of tenofovir or abacavir and either
emtricitabine or lamivudine PLUS raltegravir. Subjects on ART should plan to remain on the same therapy for at least 12 weeks after Day 1.
•CD4+ T-cell count > 300 cells/mm3 at screening.
•Have undetectable plasma HIV-1 RNA at screening and history of having achieved undetectable (i.e., below the limit of assay detetion) plasma HIV-1 RNA by
any FDA-approved test for quantifying HIV-1 RNA at any laboratory that has
a CLIA certification or its equivalent and no history of HIV-1 virologic failure (HIV-1 RNA = 200 copies/mL confirmed on two consecutive tests at least 2 weeks apart in subjects compliant with their HIV ARV therapies) for at least 24 Weeks prior to study entry
•Has not ever failed more than 1 past HIV treatment regimen
7. Agree to two acceptable methods of birth control from at least 2 weeks
prior to Day 1 and continue until at least 6 months after last dose of study drug, or
longer if dictated by local regulations (for female subject who is of childbearing
potential or male subject with female sexual partner who is of childbearing potential).
If acceptable by local regulatory agencies, methods of birth control allowed in the
study are: intrauterine device (IUD), diaphragm with spermicide, hormonal
contraceptives (e.g., birth control pills, transdermal patch, or injectables),
contraceptive sponge, female condom, male condom with spermicide, vasectomy, and true abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of postovulation methods) and withdrawal are not acceptable methods of contraception].
True abstinence does not require a second method of birth control.
For the purposes of this protocol, a woman of non-childbearing potential is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oopherectomy with or without hysterectomy, or 3) bilateral tubal ligation.
For the purposes of this protocol, a male subject who is not of reproductive potential
is eligible without requiring the use of contraception. A male subject who is not of
reproductive potential is defined as: one who has undergone a successful vasectomy.
A successful vasectomy is defined as: (1) microscopic documentation of
azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
8. understand
1. is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
2. has a non-GT1 HCV infection, including mixed GT infection (with a non-GT 1) or a nontypeable genotype.
3. Has previously received any HCV direct-acting antivirals.
4. Evidence of decompensated liver disease manifested by the presence of or history of ascites, variceal bleeding, or hepatic encephalopathy. If hepatic cirrhosis is determined by liver biopsy (Stage 4 Metavir or Stage 5, 6 Ishak) or by imaging, then participants must
be no more than Child-Pugh Class A and have a Child-Pugh-Turcotte (CPT) score of 6 or less.
5. Is determined to be HIV positive (N/A for study arm 12 and 13) and is determined to be coinfected with hepatitis B virus (e.g. HBsAg positive)
6. has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
7. is taking or plans to take any of the prohibited medications listed in Section 5 of this protocol within 2 weeks of Day 1.
8. is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or
additional data, beyond that specified in this protocol, is prohibited (other than that
related to subject’s medical care).
9. has a clinical diagnosis of substance abuse
10. has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ, squamous cell skin cancer, and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
11. (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criterion #5); or male subject is
planning to impregnate or provide sperm donation or has a female sexual partner of
childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criterion #5).
12. is a male whose female partner is/are pregnant (this is a contraindication for RBV use).
13. has any other condition which, in the opinion of the principal investigator or study physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study, including but not limited to:
•Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
•Poor venous access that precludes routine peripheral blood sampling required for this trial.
•Subject with indwelling venous catheters.
•Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a
history of malabsorption disorders (e.g., celiac sprue disease).
•Hemoglobinopathy, including, but not limited to, thalassemia major.
•Current or history of any clinically significant cardiac abnormalities / dysfunction (e.g., angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenit
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