HIV-1 InfectionPhase 1NCT02858401

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

A Phase 1 study testing Vesatolimod and ARV regimen in people with HIV-1 Infection, run by Gilead Sciences at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Vesatolimod and ARV regimen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 8 sitesUnited States
Study dates: 29 Jan 2015to 14 Feb 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 21Show fewer

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

Who cannot join

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

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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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Central Texas Clinical Research
Austin, Texas, 78705
Ohio State University Infectious Diseases Research
Columbus, Ohio, 43210
Midway Immunology & Research Center
Ft. Pierce, Florida, 34982
Mills Clinical Research
Los Angeles, California, 90069
Orlando Immunology Center Recruiting
Orlando, Florida, 32803
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UCSD Antiviral Research Center (AVRC)
San Diego, California, 92103
Peter Shalit, MD
Seattle, Washington, 98104

Other trials in United States

About this study

Official 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

Conditions: HIV-1 Infection
Being tested: Vesatolimod, Placebo, ARV regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VesatolimodDrug
Also called GS-9620
Tablet(s) administered orally once every 2 weeks
PlaceboDrug
Tablet(s) administered orally once every 2 weeks
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.

Study groups in NCT02858401
Study group	Role	What they receive
Vesatolimod 1 mg (Cohort 1)	Experimental	Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen Receives: Drug: Vesatolimod; Drug: ARV regimen
Vesatolimod 2 mg (Cohort 2)	Experimental	Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen Receives: Drug: Vesatolimod; Drug: ARV regimen
Vesatolimod 4 mg (Cohort 3)	Experimental	Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen Receives: Drug: Vesatolimod; Drug: ARV regimen
Vesatolimod 6 mg (Cohort 4)	Experimental	Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen Receives: Drug: Vesatolimod; Drug: ARV regimen
Vesatolimod 8 mg (Cohort 5)	Experimental	Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen Receives: Drug: Vesatolimod; Drug: 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) Receives: Drug: Vesatolimod; Drug: 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 Receives: Drug: Vesatolimod; Drug: 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 Receives: Drug: Vesatolimod; Drug: 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 Receives: Drug: Vesatolimod; Drug: ARV regimen
Placebo (Cohorts 1-9)	Placebo comparator	Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen Receives: Drug: Placebo; Drug: ARV regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
Measured: 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.
Measured: 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
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.
Measured: Baseline; Day 2
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.
Measured: Baseline; Day 3
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.
Measured: Baseline; Day 5
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.
Measured: Baseline; Day 8
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.
Measured: Baseline; Day 11
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.
Measured: Baseline; Day 15
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.
Measured: Baseline; Day 17
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.
Measured: Baseline; Day 19
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.
Measured: Baseline; Day 22
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.
Measured: Baseline; Day 25
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.
Measured: Baseline; Day 29
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.
Measured: Baseline; Day 31
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.
Measured: Baseline; Day 33
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36
Measured: Baseline; Day 36
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39
Measured: Baseline; Day 39
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43
Measured: Baseline; Day 43
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45
Measured: Baseline; Day 45
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47
Measured: Baseline; Day 47
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.
Measured: Baseline; Day 50
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53
Measured: Baseline; Day 53
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.
Measured: Baseline; Day 57
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.
Measured: Baseline; Day 58
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.
Measured: Baseline; Day 59
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.
Measured: Baseline; Day 61
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.
Measured: Baseline; Day 64
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.
Measured: Baseline; Day 67
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.
Measured: Baseline; Day 71
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.
Measured: Baseline; Day 73
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.
Measured: Baseline; Day 75
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.
Measured: Baseline; Day 78
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.
Measured: Baseline; Day 81
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.
Measured: Baseline; Day 85
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.
Measured: Baseline; Day 87
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.
Measured: Baseline; Day 92
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.
Measured: Baseline; Day 99
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.
Measured: Baseline; Day 101
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.
Measured: Baseline; Day 106
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.
Measured: Baseline; Day 113
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.
Measured: Baseline; Day 115
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.
Measured: Baseline; Day 120
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.
Measured: Baseline; Day 127
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.
Measured: Baseline; Day 128
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.
Measured: Baseline; Day 129
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.
Measured: Baseline; Day 134
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.
Measured: Baseline; Day 157
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1
Measured: Postdose 1 on Day 1
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15
Measured: PostDose 2 on Day 15
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29
Measured: PostDose 3 on Day 29
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43
Measured: PostDose 4 on Day 43
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57
Measured: PostDose 5 on Day 57
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71
Measured: PostDose 6 on Day 71
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85
Measured: PostDose 7 on Day 85
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99
Measured: PostDose 8 on Day 99
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113
Measured: PostDose 9 on Day 113
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127
Measured: PostDose 10 on Day 127

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 201514 Feb 2019

First posted8 Aug 2016 (estimated)
Study start29 Jan 2015
Primary completion14 Feb 2019
Study completion14 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02858401
Sponsor's protocol ID: GS-US-382-1450
Status last verified: Feb 2020
First submitted: 26 Jul 2016
Last updated: 21 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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
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.
PubMed 33043969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02858401
Acronym / sponsor ID: GS-US-382-1450
Conditions: HIV-1 Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 29 Jan 2015 (actual)
Primary completion: 14 Feb 2019 (actual)
Study completion: 14 Feb 2019 (actual)
First posted: 8 Aug 2016 (estimated)
Results: Posted 21 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Vesatolimod 1 mg (Cohort 1)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 1 mg for 71 days, while continuing their existing ARV regimen
Vesatolimod 2 mg (Cohort 2)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 2 mg for 71 days, while continuing their existing ARV regimen
Vesatolimod 4 mg (Cohort 3)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 4 mg for 71 days, while continuing their existing ARV regimen
Vesatolimod 6 mg (Cohort 4)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 6 mg for 127 days, while continuing their existing ARV regimen
Vesatolimod 8 mg (Cohort 5)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen
Vesatolimod 10 or 12 mg (Cohort 6)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 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)
Vesatolimod 12 mg (Optional Cohort 7)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 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
Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 6 mg for 127 days for up to 10 total doses administered with an acidic solution (cranberry juice), while continuing their existing ARV regimen
Vesatolimod up to 12 mg (Cohort 9)	Experimental	Drug: Vesatolimod, Drug: ARV regimenVesatolimod 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
Placebo (Cohorts 1-9)	Placebo comparator	Drug: Placebo, Drug: ARV regimenPlacebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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
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)

Key exclusion criteria (9 listed)

Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody (HCVAb) positive
Documented history of pre-ART CD4 nadir < 200 cells/µL
A new AIDS-defining condition diagnosed within 90 days prior to screening
Acute febrile illness within 35 days prior to pre-baseline/Day -13

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VesatolimodAlso: GS-9620Tablet(s) administered orally once every 2 weeks	Drug	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)
PlaceboTablet(s) administered orally once every 2 weeks	Drug	Placebo (Cohorts 1-9)
ARV regimenParticipants' 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.	Drug	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)

Primary outcome

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.

55 secondary outcomes

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 at Day 3
Time frame: Baseline; 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 at Day 8
Time frame: Baseline; 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 at Day 15
Time frame: Baseline; 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 at Day 19
Time frame: Baseline; 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 at Day 25
Time frame: Baseline; 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 at Day 31
Time frame: Baseline; 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 at Day 36
Time frame: Baseline; 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 at Day 43
Time frame: Baseline; 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 at Day 47
Time frame: Baseline; 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 at Day 53
Time frame: Baseline; 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 at Day 58
Time frame: Baseline; 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 at Day 61
Time frame: Baseline; 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 at Day 67
Time frame: Baseline; 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 at Day 73
Time frame: Baseline; 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 at Day 78
Time frame: Baseline; 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 at Day 85
Time frame: Baseline; 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 at Day 92
Time frame: Baseline; 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 at Day 101
Time frame: Baseline; 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 at Day 113
Time frame: Baseline; 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 at Day 120
Time frame: Baseline; Day 120

Results and safety

Results posted to the registry on 21 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vesatolimod 1 mg (Cohort 1)	6	6
Vesatolimod 2 mg (Cohort 2)	6	5
Vesatolimod 4 mg (Cohort 3)	6	6
Vesatolimod 6 mg (Cohort 4)	6	6
Vesatolimod 8 mg (Cohort 5)	6	6
Vesatolimod 10 or 12 mg (Cohort 6)	6	5
Placebo	12	12

Primary outcome: 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. Number. Unit: percentage of participants

Measure	Vesatolimod 1 mg (Cohort 1) n = 6	Vesatolimod 2 mg (Cohort 2) n = 6	Vesatolimod 4 mg (Cohort 3) n = 6	Vesatolimod 6 mg (Cohort 4) n = 6	Vesatolimod 8 mg (Cohort 5) n = 6	Vesatolimod 10 or 12 mg (Cohort 6) n = 6	Placebo n = 12
SAEs	0.0	16.7	0.0	0.0	0.0	0.0	0.0
AEs	66.7	66.7	33.3	66.7	83.3	66.7	75.0

Population analysed: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Primary outcome: 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. Mean (Standard Error). Unit: Log10 copies/mL

Measure	Vesatolimod 1 mg (Cohort 1) n = 6	Vesatolimod 2 mg (Cohort 2) n = 6	Vesatolimod 4 mg (Cohort 3) n = 6	Vesatolimod 6 mg (Cohort 4) n = 6	Vesatolimod 8 mg (Cohort 5) n = 6	Vesatolimod 10 or 12 mg (Cohort 6) n = 6	Placebo n = 12
Value	0.06 (0.141)	0.01 (0.018)	0.10 (0.252)	0.04 (0.092)	0.00 (0.000)	0.07 (0.073)	0.42 (0.729)

Vesatolimod 1 mg (Cohort 1) vs Placebo: p = 0.1498, Wilcoxon rank sum test
Vesatolimod 2 mg (Cohort 2) vs Placebo: p = 0.0640, Wilcoxon rank sum test
Vesatolimod 4 mg (Cohort 3) vs Placebo: p = 0.2807, Wilcoxon rank sum test

Population analysed: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

55 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Vesatolimod 1 mg (Cohort 1)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Vesatolimod 2 mg (Cohort 2)	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6
Vesatolimod 4 mg (Cohort 3)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Vesatolimod 6 mg (Cohort 4)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Vesatolimod 8 mg (Cohort 5)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Vesatolimod 10 or 12 mg (Cohort 6)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Placebo	0 of 12 (0%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationRiddler 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
Derived from this study: PubMed 33043969Riddler 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vesatolimod and ARV regimen in people with HIV-1 Infection, run by Gilead Sciences at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02858401, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.