Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02073656
First received: February 25, 2014
Last updated: June 11, 2014
Last verified: June 2014

February 25, 2014
June 11, 2014
February 2014
March 2015   (final data collection date for primary outcome measure)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (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 to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02073656 on ClinicalTrials.gov Archive Site
  • Proportion 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 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
  • Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in HCV RNA from Baseline [ Time Frame: Baseline to posttreatment Week 24 ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Baseline to posttreatment Week 24 ] [ Designated as safety issue: No ]
    Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), nonresponse (HCV RNA ≥ LLOQ through 12 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks posttreatment).
  • For retreatment group only: Proportion of participants with sustained virologic response at 4, 12 and 24 weeks after discontinuation of therapy (SVR4, SVR12, and SVR24) [ Time Frame: Posttreatment Weeks 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Proportion of participants that maintain HIV-1 RNA < 50 copies/mL while on treatment [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline of serum creatinine at end of treatment, posttreatment weeks 12 and 24 [ Time Frame: Week 12 and posttreatment weeks 12 and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C Virus
  • HIV
  • Drug: LDV/SOF
    LDV 90 mg/ SOF 400 mg FDC tablet administered orally once daily
    Other Names:
    • GS-7977
    • PSI-7977
    • GS-5885
  • Drug: RBV
    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
  • Experimental: LDV/SOF 12 weeks
    Participants will receive LDV/SOF for 12 weeks.
    Intervention: Drug: LDV/SOF
  • Experimental: Retreatment substudy
    Participants in the retreatment substudy will receive LDV/SOF plus RBV for 24 weeks.
    Interventions:
    • Drug: LDV/SOF
    • 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
300
June 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HCV RNA ≥ 10,000 IU/mL at screening
  • HCV genotype 1 or 4
  • HIV-1 infection
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Current or prior history of Clinical hepatic decompensation Hepatocellular carcinoma (HCC) or other Malignancy (with the exception of certain resolved skin cancers)
  • Hepatitis B virus (HBV) infection
  • Pregnant or nursing female
  • Chronic use of systemically administered immunosuppressive agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico,   Canada,   New Zealand
 
NCT02073656
GS-US-337-0115
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Jenny Yang, PharmD Gilead Sciences
Gilead Sciences
June 2014

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