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ASTRAL-5: Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02480712
Collaborator
(none)
107
Enrollment
15
Locations
1
Arm
11.7
Actual Duration (Months)
7.1
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Apr 29, 2016
Actual Study Completion Date :
Jun 22, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: SOF/VEL

Participants will receive SOF/VEL for 12 weeks

Drug: SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • GS-7977/GS-5816
  • Epclusa®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [Posttreatment Week 12]

      SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

    2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [Up to 12 weeks]

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]

      SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    2. Percentage of Participants With HCV RNA < LLOQ on Treatment [Up to 12 Weeks]

    3. HCV RNA Change From Baseline/Day 1 [Baseline to Week 12]

    4. Percentage of Participants With Virologic Failure [Up to Posttreatment Week 24]

      Virologic failure was defined as: On-treatment virologic failure: 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 Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit

    5. Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment [Up to 12 Weeks]

    6. Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 [Week 12; Posttreatment Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • HCV RNA ≥ 10^4 IU/mL at screening

    • HCV genotype 1, 2, 3, 4, 5, 6

    • Cirrhosis determination, a fibroscan or liver biopsy may be required

    • HIV-1 infection

    • Use of protocol specified method(s) of contraception

    • Screening laboratory values within defined thresholds

    Key Exclusion Criteria:

    • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's 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)

    • Screening ECG with clinically significant abnormalities

    • Pregnant or nursing female or male with pregnant female partner

    • Infection with hepatitis B virus (HBV)

    • Use of any prohibited concomitant medications as described in the protocol

    • Chronic use of systemically administered immunosuppressive agents

    NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Los Angeles California United States
    3 San Diego California United States
    4 San Francisco California United States
    5 Torrance California United States
    6 Atlanta Georgia United States
    7 Chicago Illinois United States
    8 Baltimore Maryland United States
    9 Lutherville Maryland United States
    10 Boston Massachusetts United States
    11 Bronx New York United States
    12 New York New York United States
    13 Durham North Carolina United States
    14 Cincinnati Ohio United States
    15 Richmond Virginia United States

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02480712
    Other Study ID Numbers:
    • GS-US-342-1202
    First Posted:
    Jun 24, 2015
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Coinfection
    Hepatitis
    Sofosbuvir
    Sofosbuvir-velpatasvir drug combination
    Velpatasvir

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.
    Pre-assignment Detail 149 participants were screened.
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Period Title: Overall Study
    STARTED 107
    COMPLETED 96
    NOT COMPLETED 11

    Baseline Characteristics

    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Overall Participants 106
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54
    (9.0)
    Sex: Female, Male (Count of Participants)
    Female
    15
    14.2%
    Male
    91
    85.8%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    48
    45.3%
    White
    54
    50.9%
    Asian
    3
    2.8%
    Other
    1
    0.9%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    15
    14.2%
    Not Hispanic or Latino
    91
    85.8%
    IL28b Status (Count of Participants)
    CC
    24
    22.6%
    CT
    52
    49.1%
    TT
    30
    28.3%
    HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 IU/mL]
    6.3
    (0.57)
    HCV RNA Category (Count of Participants)
    < 800,000 IU/mL
    28
    26.4%
    ≥ 800,000 IU/mL
    78
    73.6%
    HIV RNA category (Count of Participants)
    HIV RNA < 50 copies/mL
    55
    51.9%
    HIV RNA ≥ 50 copies/mL
    1
    0.9%
    HIV RNA < 50 copies/mL
    35
    33%
    HIV RNA ≥ 50 copies/mL
    0
    0%
    HIV RNA < 50 copies/mL
    14
    13.2%
    HIV RNA ≥ 50 copies/mL
    1
    0.9%
    Serum Creatinine (mg/dL) [Mean (Standard Deviation) ]
    Boosted TDF Containing Regimens
    1.02
    (0.194)
    Non-Boosted TDF Containing Regimens
    0.98
    (1.44)
    Non TDF Containing Regimens
    1.02
    (0.255)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
    Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
    Time Frame Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set: All enrolled participants who received at least one dose of study drug.
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    Number (95% Confidence Interval) [percentage of participants]
    95.3
    89.9%
    2. Primary Outcome
    Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
    Description
    Time Frame Up to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    Number [percentage of participants]
    1.9
    1.8%
    3. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    Description SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
    Time Frame Posttreatment Weeks 4 and 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    SVR4
    95.3
    89.9%
    SVR24
    95.3
    89.9%
    4. Secondary Outcome
    Title Percentage of Participants With HCV RNA < LLOQ on Treatment
    Description
    Time Frame Up to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    Week 1
    25.7
    24.2%
    Week 2
    68.0
    64.2%
    Week 4
    92.2
    87%
    Week 6
    99.0
    93.4%
    Week 8
    100.0
    94.3%
    Week 10
    100.0
    94.3%
    Week 12
    100.0
    94.3%
    5. Secondary Outcome
    Title HCV RNA Change From Baseline/Day 1
    Description
    Time Frame Baseline to Week 12

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    Change at Week 1
    -4.47
    (0.606)
    Change at Week 2
    -4.97
    (0.577)
    Change at Week 4
    -5.15
    (0.560)
    Change at Week 6
    -5.18
    (0.572)
    Change at Week 8
    -5.17
    (0.575)
    Change at Week 10
    -5.17
    (0.575)
    Change at Week 12
    -5.17
    (0.575)
    6. Secondary Outcome
    Title Percentage of Participants With Virologic Failure
    Description Virologic failure was defined as: On-treatment virologic failure: 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 Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
    Time Frame Up to Posttreatment Week 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title SOF/VEL 12 Weeks
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
    Measure Participants 106
    Number [percentage of participants]
    1.9
    1.8%
    7. Secondary Outcome
    Title Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
    Description
    Time Frame Up to 12 Weeks

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline: Boosted TDF-containing regimens Non-boosted TDF-containing regimens Non TDF-containing regimens
    Arm/Group Title SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group. SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents). SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
    Measure Participants 56 35 15
    Week 4
    94.4
    89.1%
    97.1
    NaN
    100
    NaN
    Week 8
    96.3
    90.8%
    97.1
    NaN
    100
    NaN
    Week 12
    96.2
    90.8%
    100
    NaN
    92.9
    NaN
    8. Secondary Outcome
    Title Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
    Description
    Time Frame Week 12; Posttreatment Week 12

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline: Boosted TDF-containing regimens Non-boosted TDF-containing regimens Non TDF-containing regimens
    Arm/Group Title SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group. SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents). SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
    Measure Participants 56 35 15
    Change at Week 12
    0.09
    (0.196)
    0.04
    (0.107)
    0.00
    (0.083)
    Change at Posttreatment Week 12
    0.04
    (0.153)
    0.02
    (0.142)
    -0.06
    (0.204)

    Adverse Events

    Time Frame Up to 12 Weeks Plus 30 Days
    Adverse Event Reporting Description Safety Analysis Set
    Arm/Group Title SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group. SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents). SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
    All Cause Mortality
    SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/56 (3.6%) 0/35 (0%) 0/15 (0%)
    Infections and infestations
    Localised infection 1/56 (1.8%) 0/35 (0%) 0/15 (0%)
    Sepsis 1/56 (1.8%) 0/35 (0%) 0/15 (0%)
    Urinary tract infection bacterial 1/56 (1.8%) 0/35 (0%) 0/15 (0%)
    Nervous system disorders
    Radial nerve palsy 1/56 (1.8%) 0/35 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    SOF/VEL 12 Weeks (Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) SOF/VEL 12 Weeks (Non TDF Containing Regimens)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/56 (60.7%) 19/35 (54.3%) 9/15 (60%)
    Gastrointestinal disorders
    Abdominal distension 3/56 (5.4%) 2/35 (5.7%) 0/15 (0%)
    Constipation 2/56 (3.6%) 2/35 (5.7%) 0/15 (0%)
    Diarrhoea 6/56 (10.7%) 2/35 (5.7%) 0/15 (0%)
    Nausea 4/56 (7.1%) 2/35 (5.7%) 1/15 (6.7%)
    Toothache 0/56 (0%) 0/35 (0%) 1/15 (6.7%)
    Vomiting 1/56 (1.8%) 1/35 (2.9%) 1/15 (6.7%)
    General disorders
    Chest discomfort 0/56 (0%) 1/35 (2.9%) 1/15 (6.7%)
    Fatigue 16/56 (28.6%) 7/35 (20%) 3/15 (20%)
    Immune system disorders
    Seasonal allergy 0/56 (0%) 2/35 (5.7%) 0/15 (0%)
    Infections and infestations
    Bronchitis 3/56 (5.4%) 0/35 (0%) 0/15 (0%)
    Fungal infection 0/56 (0%) 0/35 (0%) 1/15 (6.7%)
    Nasopharyngitis 3/56 (5.4%) 2/35 (5.7%) 0/15 (0%)
    Upper respiratory tract infection 8/56 (14.3%) 1/35 (2.9%) 0/15 (0%)
    Urinary tract infection 2/56 (3.6%) 0/35 (0%) 2/15 (13.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 6/56 (10.7%) 1/35 (2.9%) 1/15 (6.7%)
    Back pain 0/56 (0%) 2/35 (5.7%) 0/15 (0%)
    Flank pain 0/56 (0%) 0/35 (0%) 1/15 (6.7%)
    Muscle spasms 1/56 (1.8%) 0/35 (0%) 1/15 (6.7%)
    Osteoarthritis 0/56 (0%) 0/35 (0%) 1/15 (6.7%)
    Pain in extremity 2/56 (3.6%) 1/35 (2.9%) 1/15 (6.7%)
    Nervous system disorders
    Headache 7/56 (12.5%) 6/35 (17.1%) 1/15 (6.7%)
    Psychiatric disorders
    Abnormal dreams 3/56 (5.4%) 1/35 (2.9%) 0/15 (0%)
    Depression 3/56 (5.4%) 1/35 (2.9%) 0/15 (0%)
    Insomnia 4/56 (7.1%) 3/35 (8.6%) 0/15 (0%)
    Nervousness 0/56 (0%) 0/35 (0%) 1/15 (6.7%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/56 (1.8%) 2/35 (5.7%) 0/15 (0%)
    Sinus congestion 2/56 (3.6%) 2/35 (5.7%) 0/15 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 2/56 (3.6%) 0/35 (0%) 1/15 (6.7%)
    Rash 1/56 (1.8%) 0/35 (0%) 1/15 (6.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02480712
    Other Study ID Numbers:
    • GS-US-342-1202
    First Posted:
    Jun 24, 2015
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Apr 1, 2017