Clinical trial NCT02457611: Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection With HIV Co-Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.


Eligibility criteria: Key Inclusion Criteria:

* Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
* Confirmed HIV-1 infection
* CD4 T cell count \>200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count \> 500/μL at screening for individuals without ART
* Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non HCV etiology
* Coinfection with hepatitis B virus (HBV)
* Treatment with any investigational drug or device within 60 days of the screening visit.
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment
timeFrame: Weeks 2, 4, and 6
measure: Change From Baseline in HCV RNA at Weeks 2, 4, and 6
timeFrame: Baseline; Weeks 2, 4, and 6
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 12
measure: Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
timeFrame: Day 1; Week 6
measure: Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
timeFrame: Weeks 2, 4, 6, and Posttreatment Week 4
measure: Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
timeFrame: Baseline; Week 6; Posttreatment Week 4
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Frankfurt am Main
country: Germany
city: London
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Rockstroh JK, Bhagani S, Hyland RH, Yun C, Dvory-Sobol H, Zheng W, Brainard DM, Ingiliz P, Lutz T, Boesecke C, Nelson M. Ledipasvir-sofosbuvir for 6 weeks to treat acute hepatitis C virus genotype 1 or 4 infection in patients with HIV coinfection: an open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2017 May;2(5):347-353. doi: 10.1016/S2468-1253(17)30003-1. Epub 2017 Mar 1.