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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01783678
First received: January 31, 2013
Last updated: February 28, 2014
Last verified: February 2014

January 31, 2013
February 28, 2014
January 2013
April 2014   (final data collection date for primary outcome measure)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of treatment (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT01783678 on ClinicalTrials.gov Archive Site
  • Proportion of participants with sustained virologic response at 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
  • Proportion of participants with on-treatment virologic failure [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]

    Virologic failure is defined as either:

    • Virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), or
    • Non-response (HCV RNA persistently ≥ 25 IU/mL through 8 weeks of treatment ), or
    • Virologic relapse (HCV RNA ≥ 25 IU/mL during the posttreatment period having achieved HCV RNA < 25 IU/mL at end of treatment), or
    • Rebound (> 1 log10IU/mLincrease in HCV RNA from nadir while on treatment).
  • HCV RNA change from baseline [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
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
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 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis C
  • Human Immunodeficiency Virus
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • GS-7977
    • PSI-7977
    • Sovaldi®
  • Drug: 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)
  • Experimental: Sofosbuvir+RBV 12 weeks TN
    Treatment naive (TN) participants coinfected with HIV-1 and genotype 2 HCV infection will receive sofosbuvir plus RBV for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV 24 weeks TE
    Treatment experienced (TE) participants coinfected with HIV-1 and genotypes 2 and 3 HCV infection will receive sofosbuvir plus RBV for 24 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV 24 weeks TN
    Treatment naive (TN) participants coinfected with HIV-1 and genotypes 1, 3, and 4 HCV infection will receive sofosbuvir plus RBV for 24 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
July 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01783678
GS-US-334-0124
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP