EUCTR2014-004812-12-GB
Active, not recruiting
Phase 1
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects with Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
DrugsHarvoni
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 26
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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