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Completed

NCT Number: NCT02858401

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mills Clinical Research, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Vesatolimod

Drug

Tablet(s) administered orally once every 2 weeks

Other names: GS-9620

Placebo

Drug

Tablet(s) administered orally once every 2 weeks

ARV regimen

Drug

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1

    Time frame: Postdose 1 on Day 1

  47. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15

    Time frame: PostDose 2 on Day 15

  48. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29

    Time frame: PostDose 3 on Day 29

  49. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43

    Time frame: PostDose 4 on Day 43

  50. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57

    Time frame: PostDose 5 on Day 57

  51. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71

    Time frame: PostDose 6 on Day 71

  52. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85

    Time frame: PostDose 7 on Day 85

  53. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99

    Time frame: PostDose 8 on Day 99

  54. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113

    Time frame: PostDose 9 on Day 113

  55. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127

    Time frame: PostDose 10 on Day 127

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2016
Registry last updated
Feb 21, 2020

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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