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Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858401
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE August 8, 2016
Results First Submitted Date  ICMJE February 7, 2020
Results First Posted Date  ICMJE February 21, 2020
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE January 29, 2015
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
  • Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). [ Time Frame: For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days ]
  • Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint [ Time Frame: For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134 ]
    The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Incidence of treatment-emergent serious adverse events (SAEs) and all treatment-emergent adverse events [ Time Frame: Up to 101 days ]
  • Maximum change from baseline in plasma log10 HIV-1 RNA at any postdose timepoint up to Day 81 [ Time Frame: Up to 81 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 [ Time Frame: Baseline; Day 2 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 [ Time Frame: Baseline; Day 3 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 [ Time Frame: Baseline; Day 5 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 [ Time Frame: Baseline; Day 8 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 [ Time Frame: Baseline; Day 11 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 [ Time Frame: Baseline; Day 15 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 [ Time Frame: Baseline; Day 17 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 [ Time Frame: Baseline; Day 19 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 [ Time Frame: Baseline; Day 22 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 [ Time Frame: Baseline; Day 25 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 [ Time Frame: Baseline; Day 29 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 [ Time Frame: Baseline; Day 31 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 [ Time Frame: Baseline; Day 33 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 [ Time Frame: Baseline; Day 36 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 [ Time Frame: Baseline; Day 39 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 [ Time Frame: Baseline; Day 43 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 [ Time Frame: Baseline; Day 45 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 [ Time Frame: Baseline; Day 47 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 [ Time Frame: Baseline; Day 50 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 [ Time Frame: Baseline; Day 53 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 [ Time Frame: Baseline; Day 57 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 [ Time Frame: Baseline; Day 58 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 [ Time Frame: Baseline; Day 59 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 [ Time Frame: Baseline; Day 61 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 [ Time Frame: Baseline; Day 64 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 [ Time Frame: Baseline; Day 67 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 [ Time Frame: Baseline; Day 71 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 [ Time Frame: Baseline; Day 73 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 [ Time Frame: Baseline; Day 75 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 [ Time Frame: Baseline; Day 78 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 [ Time Frame: Baseline; Day 81 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 [ Time Frame: Baseline; Day 85 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 [ Time Frame: Baseline; Day 87 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 [ Time Frame: Baseline; Day 92 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 [ Time Frame: Baseline; Day 99 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 [ Time Frame: Baseline; Day 101 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 [ Time Frame: Baseline; Day 106 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 [ Time Frame: Baseline; Day 113 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 [ Time Frame: Baseline; Day 115 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 [ Time Frame: Baseline; Day 120 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 [ Time Frame: Baseline; Day 127 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 [ Time Frame: Baseline; Day 128 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 [ Time Frame: Baseline; Day 129 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 [ Time Frame: Baseline; Day 134 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.
  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 [ Time Frame: Baseline; Day 157 ]
    Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 [ Time Frame: Postdose 1 on Day 1 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 [ Time Frame: PostDose 2 on Day 15 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 [ Time Frame: PostDose 3 on Day 29 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 [ Time Frame: PostDose 4 on Day 43 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 [ Time Frame: PostDose 5 on Day 57 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 [ Time Frame: PostDose 6 on Day 71 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 [ Time Frame: PostDose 7 on Day 85 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 [ Time Frame: PostDose 8 on Day 99 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 [ Time Frame: PostDose 9 on Day 113 ]
  • Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 [ Time Frame: PostDose 10 on Day 127 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Change from baseline in plasma log10 HIV-1 RNA at post-baseline visits [ Time Frame: Up to 101 days ]
  • Proportion of participants with plasma HIV-1 RNA > 50 copies/mL at any postdose timepoint [ Time Frame: Up to 81 days ]
  • Change in single copy assay (SCA) from predose to 2 days postdose [ Time Frame: Predose to 2 days postdose ]
  • Change in cell-associated HIV-1 RNA from predose to 2 days postdose [ Time Frame: Predose to 2 days postdose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
Official Title  ICMJE A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Escalation Study of the Safety and Biological Activity of GS-9620 in HIV-1 Infected, Virologically Suppressed Adults
Brief Summary The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Name: GS-9620
  • Drug: Placebo
    Tablet(s) administered orally once every 2 weeks
  • Drug: ARV regimen
    Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Study Arms  ICMJE
  • Experimental: Vesatolimod 1 mg (Cohort 1)
    Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 2 mg (Cohort 2)
    Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 4 mg (Cohort 3)
    Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 6 mg (Cohort 4)
    Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 8 mg (Cohort 5)
    Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 10 or 12 mg (Cohort 6)
    Vesatolimod 10 or 12 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen. Participants will receive 3 administrations of 10 mg, followed by 7 administrations of 12 mg (after review of 10 mg safety data)
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 12 mg (Optional Cohort 7)
    Vesatolimod up to 12 mg for up to 127 days for up to 10 total doses administered following overnight fasting, while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)
    Vesatolimod 6 mg for 127 days for up to 10 total doses administered with an acidic solution (cranberry juice), while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Experimental: Vesatolimod up to 12 mg (Cohort 9)
    Vesatolimod up to 12 mg for 127 days for up to 10 total doses administered following a moderate-fat meal, after the review of the data from the highest tolerated fasted dose cohort while continuing their existing ARV regimen
    Interventions:
    • Drug: Vesatolimod
    • Drug: ARV regimen
  • Placebo Comparator: Placebo (Cohorts 1-9)
    Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen
    Interventions:
    • Drug: Placebo
    • Drug: ARV regimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
24
Actual Study Completion Date  ICMJE February 14, 2019
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • HIV-1 infection
  • Aged ≥ 18 years at Pre-baseline/Day -13
  • On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13

    • The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc
    • The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
    • A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
  • Plasma HIV-1 RNA < 50 copies/mL at screening
  • Documented plasma HIV-1 RNA levels < 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)

    • Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
    • If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA <50 copies/mL at Pre-baseline/Day -13 visit is required
  • No documented history of resistance to any components of the current ARV regimen
  • Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance
  • Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
  • White blood cells (WBC) ≥ 4,000 cells/μL
  • Platelets ≥ 150,000/mL
  • Absolute neutrophil count (ANC) ≥ 1500 cells/μL
  • CD4 count ≥ 400 cells/μL
  • Albumin ≥ 3.9 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)
  • Estimated glomerular filtration rate ≥ 60 mL/min
  • No autoimmune disease

Key Exclusion Criteria:

  • Hepatitis B surface antigen (HBsAg) positive

    • Positive anti-HBs antibody and negative HBsAg results are acceptable
  • Hepatitis C antibody (HCVAb) positive

    • Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
  • Documented history of pre-ART CD4 nadir < 200 cells/µL

    • Unknown pre-ART CD4 nadir is acceptable
  • A new AIDS-defining condition diagnosed within 90 days prior to screening
  • Acute febrile illness within 35 days prior to pre-baseline/Day -13

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02858401
Other Study ID Numbers  ICMJE GS-US-382-1450
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date February 2020

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