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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02073656




Registration number
NCT02073656
Ethics application status
Date submitted
25/02/2014
Date registered
27/02/2014
Date last updated
16/11/2018

Titles & IDs
Public title
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Scientific title
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection
Secondary ID [1] 0 0
GS-US-337-0115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 0 0
HIV 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LDV/SOF
Treatment: Drugs - RBV

Experimental: LDV/SOF 12 Weeks - LDV/SOF for 12 weeks

Experimental: Retreatment Substudy - LDV/SOF plus RBV for 24 weeks


Treatment: Drugs: LDV/SOF
90/400 mg FDC tablet administered orally once daily

Treatment: Drugs: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) - SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) - SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Timepoint [1] 0 0
Posttreatment Weeks 4 and 24
Secondary outcome [2] 0 0
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Timepoint [2] 0 0
Weeks 1, 2, 4, 6, 8, 10, and 12
Secondary outcome [3] 0 0
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Timepoint [3] 0 0
Baseline; Weeks 1, 2, 4, 6, and 8
Secondary outcome [4] 0 0
Percentage of Participants With Virologic Failure - Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Timepoint [4] 0 0
Up to Posttreatment Week 24
Secondary outcome [5] 0 0
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Timepoint [5] 0 0
Weeks 4, 8, and 12
Secondary outcome [6] 0 0
Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
Timepoint [6] 0 0
Baseline; Week 12, Posttreatment Weeks 12 and 24
Secondary outcome [7] 0 0
For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24) - SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.
Timepoint [7] 0 0
Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy
Secondary outcome [8] 0 0
For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Timepoint [8] 0 0
Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy
Secondary outcome [9] 0 0
For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Timepoint [9] 0 0
Baseline; Weeks 2, 4, and 8 of Retreatment Substudy
Secondary outcome [10] 0 0
For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure - Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Timepoint [10] 0 0
Up to Posttreatment Week 24 of Retreatment Substudy

Eligibility
Key inclusion criteria
- HCV RNA = 10,000 IU/mL at screening

- HCV genotype 1 or 4

- HIV-1 infection

- Cirrhosis determination, a fibroscan or liver biopsy may be required

- Screening laboratory values within defined thresholds

- Use of protocol specified method(s) of contraception if female of childbearing
potential or sexually active male
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically-significant illness (other than HCV or HIV) or any other major medical
disorder that may interfere with subject treatment, assessment, or compliance with the
protocol

- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma
(HCC), or other malignancy (with the exception of certain resolved skin cancers)

- Hepatitis B virus (HBV) infection

- Pregnant or nursing female

- Chronic use of systemically administered immunosuppressive agents

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
New Zealand
State/province [24] 0 0
Christchurch
Country [25] 0 0
Puerto Rico
State/province [25] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the antiviral efficacy, safety, and tolerability of
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in
hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment
intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with
HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before
Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive
LDV/SOF plus ribavirin (RBV) for 24 weeks.
Trial website
https://clinicaltrials.gov/show/NCT02073656
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jenny Yang, PharmD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications