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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01783678




Registration number
NCT01783678
Ethics application status
Date submitted
31/01/2013
Date registered
5/02/2013
Date last updated
30/04/2015

Titles & IDs
Public title
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Scientific title
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Secondary ID [1] 0 0
GS-US-334-0124
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Human Immunodeficiency Virus 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
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

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

Experimental: Genotype 2 treatment-naive - Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.

Experimental: Genotype 2/3 treatment-experienced - Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.

Experimental: Genotype 1/3/4 treatment-naive - Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.


Treatment: Drugs: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily

Treatment: Drugs: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 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) at 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Timepoint [1] 0 0
Posttreatment Weeks 4 and 24
Secondary outcome [2] 0 0
HCV RNA Change From Baseline at Week 1
Timepoint [2] 0 0
Baseline; Week 1
Secondary outcome [3] 0 0
HCV RNA Change From Baseline at Week 2
Timepoint [3] 0 0
Baseline; Week 2
Secondary outcome [4] 0 0
HCV RNA Change From Baseline at Week 4
Timepoint [4] 0 0
Baseline; Week 4
Secondary outcome [5] 0 0
HCV RNA Change From Baseline at Week 6
Timepoint [5] 0 0
Baseline; Week 6
Secondary outcome [6] 0 0
HCV RNA Change From Baseline at Week 8
Timepoint [6] 0 0
Baseline; Week 8
Secondary outcome [7] 0 0
Percentage of Participants Experiencing Virologic Failure
Timepoint [7] 0 0
Baseline up to Posttreatment Week 24

Eligibility
Key inclusion criteria
- Age = 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection

- HCV RNA > 10,000 IU/mL at screening

- HCV treatment history:

- Treatment-naive for HCV genotypes 1, 2, 3, or 4, or

- Treatment-experienced for HCV genotypes 2 or 3

- HIV antiretroviral (ARV) criteria:

- On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8
weeks prior to screening, or

- ARV untreated for = 8 weeks prior to screening, with a CD4 T-cell count > 500
cells/mm^3

- Presence or absence of cirrhosis; a liver biopsy may be required

- Healthy according to medical history and physical examination with the exception of
HCV and HIV diagnosis

- Agree to use two forms of highly effective contraception for the duration of the study
and 6 months after the last dose of study medication
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- HCV genotype 1 or 4 with previous HCV treatment

- Poor control with HIV ARV regimen requiring a possible dose modification of therapy
within 4 weeks of study medication dosing

- A new AIDS-defining condition diagnosed within 30 days prior to screening

- Prior use of any other inhibitor of the HCV NS5B polymerase

- History of any other clinically significant chronic liver disease

- Evidence of or history of decompensated liver disease

- Chronic hepatitis B virus (HBV) infection

- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
skin cancers)

- Chronic use of immunosuppressive agents or immunomodulatory agents

- Clinically relevant drug or alcohol abuse within 12 months of screening

- History or current evidence of any condition, therapy, laboratory abnormality or other
circumstance that might confound the results of the study, or interfere with the
participant's participation for the full duration of the study or not be in the best
interest of the participant in the opinion of the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lyon
Country [2] 0 0
France
State/province [2] 0 0
Nice
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Bonn
Country [6] 0 0
Germany
State/province [6] 0 0
Duesseldorf
Country [7] 0 0
Germany
State/province [7] 0 0
Frankfurt
Country [8] 0 0
Germany
State/province [8] 0 0
Hamburg
Country [9] 0 0
Germany
State/province [9] 0 0
Würzburg
Country [10] 0 0
Italy
State/province [10] 0 0
Bergamo
Country [11] 0 0
Italy
State/province [11] 0 0
Milano
Country [12] 0 0
Italy
State/province [12] 0 0
Napoli
Country [13] 0 0
Italy
State/province [13] 0 0
Rome
Country [14] 0 0
Italy
State/province [14] 0 0
Torino
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Seville
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Glasgow
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Sussex

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV
infection who are co-infected with HIV-1.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01783678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anuj Gaggar, MD, PhD
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01783678