Trial record 20 of 44 for:    " January 23, 2013":" February 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01783678
First received: January 31, 2013
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Human Immunodeficiency Virus
Drug: Sofosbuvir
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

  • Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.


Secondary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.

  • HCV RNA Change From Baseline at Week 1 [ Time Frame: Baseline; Week 1 ] [ Designated as safety issue: No ]
  • HCV RNA Change From Baseline at Week 2 [ Time Frame: Baseline; Week 2 ] [ Designated as safety issue: No ]
  • HCV RNA Change From Baseline at Week 4 [ Time Frame: Baseline; Week 4 ] [ Designated as safety issue: No ]
  • HCV RNA Change From Baseline at Week 6 [ Time Frame: Baseline; Week 6 ] [ Designated as safety issue: No ]
  • HCV RNA Change From Baseline at Week 8 [ Time Frame: Baseline; Week 8 ] [ Designated as safety issue: No ]
  • Percentage of Participants Experiencing Virologic Failure [ Time Frame: Baseline up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

    On-treatment virologic failure was defined as either:

    • Virologic 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
    • Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).

    Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."



Enrollment: 275
Study Start Date: January 2013
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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: 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.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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: 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.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783678

Locations
Australia, New South Wales
Darlinghurst, New South Wales, Australia
Sydney, New South Wales, Australia
Australia, Victoria
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
France
Lyon, France
Nice, France
Paris, France
Germany
Berlin, Germany
Bonn, Germany
Duesseldorf, Germany
Frankfurt, Germany
Hamburg, Germany
Würzburg, Germany
Italy
Bergamo, Italy
Milano, Italy
Napoli, Italy
Rome, Italy
Torino, Italy
Spain
Barcelona, Spain
Madrid, Spain
Seville, Spain
United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Sussex, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: April 15, 2015
Last Updated: April 15, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 26, 2015