Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
Query!
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
Query!
Secondary ID [1]
0
0
GS-US-337-0115
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus
0
0
Query!
HIV
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Query!
Assessment method [1]
0
0
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Query!
Timepoint [1]
0
0
Posttreatment Week 12
Query!
Primary outcome [2]
0
0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 12 weeks
Query!
Secondary outcome [1]
0
0
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Query!
Assessment method [1]
0
0
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Query!
Timepoint [1]
0
0
Posttreatment Weeks 4 and 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Weeks 1, 2, 4, 6, 8, 10, and 12
Query!
Secondary outcome [3]
0
0
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline; Weeks 1, 2, 4, 6, and 8
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Virologic Failure
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Up to Posttreatment Week 24
Query!
Secondary outcome [5]
0
0
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Weeks 4, 8, and 12
Query!
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
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline; Week 12, Posttreatment Weeks 12 and 24
Query!
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)
Query!
Assessment method [7]
0
0
SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.
Query!
Timepoint [7]
0
0
Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy
Query!
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
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy
Query!
Secondary outcome [9]
0
0
For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline; Weeks 2, 4, and 8 of Retreatment Substudy
Query!
Secondary outcome [10]
0
0
For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Up to Posttreatment Week 24 of Retreatment Substudy
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
335
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Mexico
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Rhode Island
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
British Columbia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Ontario
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Quebec
Query!
Country [23]
0
0
New Zealand
Query!
State/province [23]
0
0
Auckland
Query!
Country [24]
0
0
New Zealand
Query!
State/province [24]
0
0
Christchurch
Query!
Country [25]
0
0
Puerto Rico
Query!
State/province [25]
0
0
San Juan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02073656
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jenny Yang, PharmD
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02073656
Download to PDF