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NCT Number: NCT01783678

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 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.

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Key information

Conditions

Chronic Hepatitis C Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg tablet administered orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

RBV

Drug

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)

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    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.

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Time frame: Up to 24 weeks

    The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.

Secondary outcomes

  1. 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

    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.

  2. HCV RNA Change From Baseline at Week 1

    Time frame: Baseline; Week 1

  3. HCV RNA Change From Baseline at Week 2

    Time frame: Baseline; Week 2

  4. HCV RNA Change From Baseline at Week 4

    Time frame: Baseline; Week 4

  5. HCV RNA Change From Baseline at Week 6

    Time frame: Baseline; Week 6

  6. HCV RNA Change From Baseline at Week 8

    Time frame: Baseline; Week 8

  7. Percentage of Participants Experiencing Virologic Failure

    Time frame: Baseline up to Posttreatment Week 24

    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."

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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