MK-5172 in Combination with MK-8742 in Subjects with HCV/HIV Co- Infectio

• Conditions: Hepatitis C; MedDRA version: 16.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000342-30-ES
• Lead Sponsor: Merck Sharp & Dohme Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. You are greater than or equal to 18 years of age
2. You have chronic HCV GT1, GT4, GT5, GT6
3. You have had a liver biopsy, Fibroscan, or Fibrotest to check for
cirrhosis or no cirrhosis
4. You are treatment naïve to all anti-HCV treatment
5. You are co-infected with HIV-1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. You have signs of decompensated liver disease
2. You are coinfected with hepatitis B virus
3. You have signs of hepatocellular carcinoma or history of malignancy
4. You are taking or plan to take any medication not allowed for this study
5. You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus
6. You have exclusionary conditions or lab values
7. You have a history of opportunistic infection
8. You have clinically relevant drug or alcohol abuse within the last 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified