An international study to assess the safety and efficacy of a combination of an approved drug combination in different type of patient, namely patients acutely infected with Hepatitis C virus who are also chronically infected with Human Immunodeficiency Virus (HIV)-1.

Phase 1

• Conditions: Acute Genotype 1 or Genotype 4 Hepatitis C Virus Infection; MedDRA version: 18.0 Level: PT Classification code 10070218 Term: Hepatitis C virus test positive System Organ Class: 10022891 - Investigations; MedDRA version: 18.0 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004812-12-GB
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Study Completion: 2016-01-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
1) Willing and able to provide written informed consent
2) Male or female, age >/=18 years
3) Body mass index (BMI) >/=18 kg/m2
4) HCV genotype 1 or 4 at Screening as determined by the Central Laboratory. Any non definitive genotype results will exclude the subject from study participation
5) Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined in the protocol
6) Confirmed HIV-1 infection and are either:
- Receiving an HIV ARV regimen as described in 5.6 with HIV RNA <200 copies/mL or
- Not receiving ART with no immediate plans to start ART during the 6 week study duration
7) CD4 T cell count >200/µl at screening in patients under receiving ART, CD4 T cell count >500/µl at screening in patients without ART
8) Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
9) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) Current or prior history of specific illness/ disorders detailed in the protocol
2) Active HBV infection with positive HBsAg. Subjects not receiving tenofovir-containing ART must also have positive HBV DNA to be excluded.
3) Prior exposure to any IFN, RBV, or other approved or experimental HCV-specific direct acting antiviral agent within the previous 6 months
4) Pregnant or nursing female
5) Chronic liver disease of a non HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa 1 antitrypsin deficiency, cholangitis)
6) In the opinion of the Investigator, active clinically-relevant alcohol or drug abuse that would present difficulties with protocol compliance
7) Use of any prohibited concomitant medications as described in Section 7.5 or 7.6
8) Drugs disallowed per respective Summary of Product Characteristics depending on subject’s ARV medication
9) ECG with clinically significant abnormalities
10) Serious abnormality on screening blood tests
11) Pregnant or nursing female or male with pregnant female partner
12) Known hypersensitivity to one of the trial drugs or its excipients
13) Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial

Study & Design

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