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.

• Register: EUCTR
• Last refreshed on: 1 February 2016
• Main ID: EUCTR2014-004812-12-DE
• Date of registration: 02/02/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences, Inc.
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 07/05/2015
• Target sample size: 25
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004812-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Germany, United Kingdom

Contacts

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences Inc

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences Inc

Key inclusion & exclusion 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
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Intervention(s)

Trade Name: Harvoni
Product Name: Ledipasvir/sofosbuvir fixed dose combination tablets
Product Code: GS-5885/GS-7977
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Current Sponsor code: GS-7977
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
INN or Proposed INN: ledipasvir
Current Sponsor code: GS-5885
Other descriptive name: GS-5885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Primary Outcome(s)

Primary end point(s): The primary endpoint is sustained virological response (SVR12), defined as HCV RNA

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 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

Timepoint(s) of evaluation of this end point: 12 weeks post last treatment dose

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment or 4 weeks following discontinuation of treatment

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

Secondary ID(s)

GS-US-337-1612

Source(s) of Monetary Support

Gilead Sciences Inc