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
This study is currently recruiting participants.
Verified February 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01783678
First received: January 31, 2013
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2, 3, and 4 HCV-infection who are co-infected with HIV-1. A total of 220 HCV subjects who are co-infected with HIV-1 will be enrolled into a single arm and treated with oral SOF 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include HCV genotype 1, 2, 3, and 4 HCV treatment naive subjects (including IFN ineligible) and HCV genotype 2 and 3 HCV treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C Human Immunodeficiency Virus |
Drug: sofosbuvir + Ribavirin (RBV) |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Ribavirin
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Efficacy of SOF + Ribavirin (RBV) [ Time Frame: 12 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]To determine the efficacy of treatment with SOF + ribavirin (RBV) by proportion of subjects with sustained viral response 12 (SVR 12) after discontinuation of therapy
- Safety and Tolerability of SOF + Ribavirin (RBV) measured by review of accumulated safety data [ Time Frame: Safety and tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of SOF + Ribavirin(RBV) as assessed by review of the accumulated safety data
Secondary Outcome Measures:
- Sustained Viral Response at 4 weeks and 24 weeks (SVR4 and SVR 24) [ Time Frame: 4 and 24 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]To determine the proportion of subjects who attain sustained viral response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
- Emergence of Viral Resistance measured by patients with viral resistance [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]To evaluate the emergence of viral resistance to SOF during treatment and after treatment discontinuation
- Kinetics of circulating HCV RNA during and after treatment discontinuation [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]On treatment and post treatment HCV RNA levels over time will be used to characterize the kinetics of circulating HCV RNA during and after treatment discontinuation.
Estimated Enrollment: | 220 |
Study Start Date: | January 2013 |
Estimated Study Completion Date: | June 2014 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1
Arm 1 ( N= 50) Experimental: SOF + Ribavirin 50 HIV-1/HCV Genotype 2 and 3 Treatment Naïve subjects will receive 12 weeks of treatment with SOF (400 mg QD) and RBV (1000-1200 mg daily)
|
Drug: sofosbuvir + Ribavirin (RBV)
Sofosbuvir (SOF): 400mg; Ribavirin (RBV): 1000 or 1200 mg/day weight based 12 week duration
|
Experimental: Arm 2
Arm 2 (n = 50)Experimental: SOF + Ribavirin 50 HIV-1/HCV Genotype 2 and 3 Treatment Experienced subjects will receive 24 weeks of treatment with SOF (400 mg QD) and RBV (1000-1200 mg daily)
|
Drug: sofosbuvir + Ribavirin (RBV)
Sofosbuvir (SOF): 400mg; Ribavirin (RBV): 1000 or 1200 mg/day weight based 24 week duration
|
Experimental: Arm 3
Arm 3 (n=120) Experimental: SOF + Ribavirin 50 HIV-1/HCV Genotype 1 and 4 Treatment Naive subjects will receive 24 weeks of treatment with SOF (400 mg QD) and RBV (1000 1200 mg daily)
|
Drug: sofosbuvir + Ribavirin (RBV)
Sofosbuvir (SOF): 400mg; Ribavirin (RBV): 1000 or 1200 mg/day weight based 24 week duration
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > or = 18 years with chronic HCV genotype 1, 2, 3, or 4 and co-infected with HIV-1 infection
- HCV RNA > 10,000 IU/mL at Screening
- HCV treatment-naïve for HCV genotypes 1, 2, 3, or 4
- Previous HCV treatment for HCV genotypes 2 or 3
- On a stable, protocol-approved, HIV antiretroviral (ARV) regimen with undetectable HIV-RNA for greater than 8 weeks prior to screening.
- Not currently receiving HIV ARVs
- 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.
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 subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783678
Contacts
Contact: Maryanne Lenoci, MA | Maryanne.Lenoci@gilead.com |
Locations
Australia, New South Wales | |
Not yet recruiting | |
Darlinghurst, New South Wales, Australia | |
Not yet recruiting | |
Sydney, New South Wales, Australia | |
Australia, Victoria | |
Recruiting | |
Melbourne, Victoria, Australia | |
Not yet recruiting | |
Parkville, Victoria, Australia | |
France | |
Not yet recruiting | |
Lyon, France | |
Not yet recruiting | |
Nice, France | |
Not yet recruiting | |
Paris, France | |
Germany | |
Not yet recruiting | |
Berlin, Germany | |
Not yet recruiting | |
Bonn, Germany | |
Not yet recruiting | |
Duesseldorf, Germany | |
Not yet recruiting | |
Frankfurt, Germany | |
Not yet recruiting | |
Hamburg, Germany | |
Not yet recruiting | |
Würzburg, Germany | |
Italy | |
Not yet recruiting | |
Bergamo, Italy | |
Not yet recruiting | |
Milano, Italy | |
Not yet recruiting | |
Napoli, Italy | |
Not yet recruiting | |
Pavia, Italy | |
Not yet recruiting | |
Rome, Italy | |
Not yet recruiting | |
Torino, Italy | |
Portugal | |
Not yet recruiting | |
Lisbon, Portugal | |
Not yet recruiting | |
Oporto, Portugal | |
Spain | |
Not yet recruiting | |
Barcelona, Spain | |
Not yet recruiting | |
Madrid, Spain | |
Not yet recruiting | |
Seville, Spain | |
United Kingdom | |
Not yet recruiting | |
Glasgow, United Kingdom | |
Not yet recruiting | |
London, United Kingdom |
Sponsors and Collaborators
Gilead Sciences
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2013
No publications provided
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01783678 History of Changes |
Other Study ID Numbers: | GS-US-334-0124 |
Study First Received: | January 31, 2013 |
Last Updated: | February 1, 2013 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Immunologic Deficiency Syndromes Virus Diseases Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 03, 2013