Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01565889
First received: March 27, 2012
Last updated: December 20, 2013
Last verified: December 2013

March 27, 2012
December 20, 2013
March 2012
August 2013   (final data collection date for primary outcome measure)
  • Part A: Evaluate whether Sofosbuvir will significantly influence the PK parameters of Antiretroviral Therapy (ART) in healthy HIV/HCV co-infected subjects. [ Time Frame: Part A: 7 days ] [ Designated as safety issue: No ]
    Part A: Evaluate whether sofosbuvir will significantly influence the PK parameters of Atazanavir/ritonavir (ATV/r), Efavirenz (EFV), Tenofovir (TDF), Emtricitabine(FTC),Zidovudine (ZDV), Lamivudine (3TC), Darunavir/ritonavir (DRV/r) or Raltegravir (RAL) in healthy HIV/HCV co-infected subjects.
  • Part B: Efficacy of Sofosbuvir + Peginterferon Alfa 2a (PEG) + Ribavirin (RBV) [ Time Frame: Part B: 12 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]
    Part B: To determine the efficacy of treatment with Sofosbuvir + PEG + RBV as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12).
  • Part B: To evaluate the safety and tolerability of Sofosbuvir + PEG + RBV as assessed by review of the accumulated safety data, including HIV-RNA and CD4 T-cell percent. [ Time Frame: Part B: Safety and Tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: No ]
Evaluate whether PSI-7977 will significantly influence the PK parameters of ATV/r, EFV, TDF, FTC, ZDV or 3TC in healthy HIV/HCV co-infected subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01565889 on ClinicalTrials.gov Archive Site
Not Provided
  • Evaluate whether ATV/r, EFV, TDF, FTC, ZDV or 3TC will significantly affect the pharmacokinetic parameters of PSI-7977 and metabolites in healthy HIV/HCV co-infected subjects compared with historical data from HCV mono-infected subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Evaluate the viral kinetics of the effect of PSI-7977 on HCV RNA in HIV/HCV co-infected subjects receiving pre-specified ART regimens for 7 days. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of 7 days of dosing of PSI-7977 in combination with ATV/r, EFV, TDF, FTC, ZDV or 3TC in healthy HIV/HCV co-infected subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir and Emtricitabine; Raltegravir, Tenofovir and Emtricitabine in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve HIV/HCV Co-infected Patients.

This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection . Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, peginterferon alfa 2a (PEG) and Ribavirin (RBV) in participants with HIV/HCV coinfection.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • HIV
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg (1 × 400-mg tablet or 2 × 200-mg tablets) administered orally once daily
    Other Names:
    • GS-7977
    • PSI-7977
  • Drug: EFV/FTC/TDF
    Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
    Other Name: Atripla®
  • Drug: EFV
    Efavirenz (EFV) 600 mg tablet administered orally once daily
    Other Name: Sustiva®
  • Drug: ZDV/3TC
    Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
    Other Name: Combivir®
  • Drug: ATV
    Atazanavir 400 mg tablet administered orally once daily
  • Drug: Ritonavir
    Ritonavir (RTV, /r) 100 mg tablet administered orally once daily
  • Drug: FTC/TDF
    FTC/TDF FDC tablet administered orally once daily
    Other Name: Truvada®
  • Drug: DRV
    Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
  • Drug: RAL
    Raltegravir (RAL) 400 mg administered administered orally twice daily
  • Drug: PEG
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
  • 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: Part A: Cohort 1
    Participants received sofosbuvir+EFV/TDF/FTC or sofosbuvir+EFV+FTC/FTD for 7 days, coadministered once daily in the evening under fasting conditions.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: EFV/FTC/TDF
  • Experimental: Part A: Cohort 2
    Participants received sofosbuvir+EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV were administered once daily in the evening under fasting conditions; ZDV/3TC was administered twice daily, in the morning without regard to food and in the evening on an empty stomach.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: EFV
    • Drug: ZDV/3TC
  • Experimental: Part A: Cohort 3
    Participants received sofosbuvir+ATV boosted with ritonavir (ATV/r)+FTC/TDF for 7 days coadministered once daily in the morning with food.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: ATV
    • Drug: Ritonavir
    • Drug: FTC/TDF
  • Experimental: Part A: Cohort 4
    Participants received sofosbuvir+DRV boosted with ritonavir (DRV/R)+FTC/TDF for 7 days coadministered once daily in the morning with food.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: FTC/TDF
    • Drug: DRV
  • Experimental: Part A: Cohort 5
    Participants received sofosbuvir+RAL+FTC/TDF for 7 days. Sofosbuvir and TFC/TDF were administered once daily in the morning with food; RAL was administered twice daily, in the morning without regard to food and in the evening without regard to food.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: FTC/TDF
    • Drug: RAL
  • Experimental: Part B
    Participants received sofosbuvir+PEG+RBV for 12 weeks and were monitored for up to 24 weeks following the last dose of study medication.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: PEG
    • Drug: RBV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
  • Confirmation of Chronic HCV infection
  • Confirmation of Chronic HIV-1 infection
  • On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
  • 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
  • Subjects must be naive to treatment for chronic HCV infection

Exclusion Criteria:

  • Known or suspected cirrhosis
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease.
  • Use of any prohibited medications as defined by the protocol
  • Pregnant or nursing female or male with pregnant female partner
  • Contraindication to PEG or RBV therapy (for Part B)
  • Clinically relevant drug or alcohol abuse
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT01565889
P7977-1910
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Anuj Gaggar, MD/PhD Gilead Sciences
Gilead Sciences
December 2013

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