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
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion 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/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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are as follows: • To determine the proportion of subjects who attain SVR at 4 weeks after discontinuation of study treatment (SVR4) • To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation • To evaluate the emergence of HCV viral resistance to SOF and LDV during treatment and after treatment discontinuation • To evaluate the change in HIV RNA from Day 1 to end of treatment • To assess, among subjects receiving ART for HIV-1, the proportion of subjects that maintain HIV-1 RNA <50 copies/mL while on HCV treatment and at Post-Treatment Week 4 • To assess the change from Day 1 in CD4 T-cell count at the end of treatment and at Post-Treatment Week 4;Primary end point(s): The primary endpoint is sustained virological response (SVR12), defined as HCV RNA <LLoQ at 12 weeks after completion of treatment;Timepoint(s) of evaluation of this end point: 12 weeks post last treatment dose;Main Objective: The primary objective of this study is as follows: • To determine the antiviral efficacy of LDV/SOF FDC Tablet as measured by the proportion of subjects who attain SVR at 12 weeks after discontinuation of therapy (SVR12) • To evaluate the safety and tolerability of LDV/SOF FDC as assessed by review of the accumulated safety data | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include the following: • The proportion of subjects with: HCV RNA < LLOQ at 4 weeks after discontinuation of study treatment (SVR4) • The proportion of subjects with HCV RNA < LLOQ on treatment • HCV RNA change from Baseline/Day 1The proportion of subjects with virologic failure ;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment or 4 weeks following discontinuation of treatment | — |
Countries
Germany, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences Inc
Outcome results
None listed