NCT02858401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 21, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

July 26, 2016

Results QC Date

February 7, 2020

Last Update Submit

February 7, 2020

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).

    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

    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.

    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

Secondary Outcomes (55)

  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2

    Baseline; Day 2

  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3

    Baseline; Day 3

  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5

    Baseline; Day 5

  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8

    Baseline; Day 8

  • Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11

    Baseline; Day 11

  • +50 more secondary outcomes

Study Arms (10)

Vesatolimod 1 mg (Cohort 1)

EXPERIMENTAL

Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 2 mg (Cohort 2)

EXPERIMENTAL

Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 4 mg (Cohort 3)

EXPERIMENTAL

Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 6 mg (Cohort 4)

EXPERIMENTAL

Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 8 mg (Cohort 5)

EXPERIMENTAL

Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 10 or 12 mg (Cohort 6)

EXPERIMENTAL

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)

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 12 mg (Optional Cohort 7)

EXPERIMENTAL

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

Drug: VesatolimodDrug: ARV regimen

Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)

EXPERIMENTAL

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

Drug: VesatolimodDrug: ARV regimen

Vesatolimod up to 12 mg (Cohort 9)

EXPERIMENTAL

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

Drug: VesatolimodDrug: ARV regimen

Placebo (Cohorts 1-9)

PLACEBO COMPARATOR

Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen

Drug: PlaceboDrug: ARV regimen

Interventions

VesatolimodDRUG

Tablet(s) administered orally once every 2 weeks

Also known as: GS-9620
Vesatolimod 1 mg (Cohort 1)Vesatolimod 10 or 12 mg (Cohort 6)Vesatolimod 12 mg (Optional Cohort 7)Vesatolimod 2 mg (Cohort 2)Vesatolimod 4 mg (Cohort 3)Vesatolimod 6 mg (Cohort 4)Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)Vesatolimod 8 mg (Cohort 5)Vesatolimod up to 12 mg (Cohort 9)
PlaceboDRUG

Tablet(s) administered orally once every 2 weeks

Placebo (Cohorts 1-9)
ARV regimenDRUG

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.

Placebo (Cohorts 1-9)Vesatolimod 1 mg (Cohort 1)Vesatolimod 10 or 12 mg (Cohort 6)Vesatolimod 12 mg (Optional Cohort 7)Vesatolimod 2 mg (Cohort 2)Vesatolimod 4 mg (Cohort 3)Vesatolimod 6 mg (Cohort 4)Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)Vesatolimod 8 mg (Cohort 5)Vesatolimod up to 12 mg (Cohort 9)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

UCSD Antiviral Research Center (AVRC)

San Diego, California, 92103, United States

Location

Midway Immunology & Research Center

Ft. Pierce, Florida, 34982, United States

Location

Orlando Immunology Center Recruiting

Orlando, Florida, 32803, United States

Location

Ohio State University Infectious Diseases Research

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Peter Shalit, MD

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Riddler S, Para M, Benson C, et al. Vesatolimod (GS-9620) is safe and pharmacodynamically active in HIV infected individuals [Oral presentation WEAA0304]. 10th International AIDS Society Conference on HIV Science (IAS 2019), 22-23 July 2019, Mexico City, Mexico

    RESULT

  • Riddler SA, Para M, Benson CA, Mills A, Ramgopal M, DeJesus E, Brinson C, Cyktor J, Jacobs J, Koontz D, Mellors JW, Laird GM, Wrin T, Patel H, Guo S, Wallin J, Boice J, Zhang L, Humeniuk R, Begley R, German P, Graham H, Geleziunas R, Brainard DM, SenGupta D. Vesatolimod, a Toll-like Receptor 7 Agonist, Induces Immune Activation in Virally Suppressed Adults Living With Human Immunodeficiency Virus-1. Clin Infect Dis. 2021 Jun 1;72(11):e815-e824. doi: 10.1093/cid/ciaa1534.

    PMID: 33043969DERIVED

MeSH Terms

Interventions

vesatolimod

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 8, 2016

Study Start

January 29, 2015

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

February 21, 2020

Results First Posted

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)