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:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
HIV-1 Infection |
Interventions |
Drug: Vesatolimod Drug: Placebo Drug: ARV regimen |
Enrollment | 48 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in United States. The first participant was screened on 29 January 2015. The last study visit occurred on 14 February 2019. |
Pre-assignment Details | 58 participants were screened. |
Arm/Group Title | Vesatolimod 1 mg (Cohort 1) | Vesatolimod 2 mg (Cohort 2) | Vesatolimod 4 mg (Cohort 3) | Vesatolimod 6 mg (Cohort 4) | Vesatolimod 8 mg (Cohort 5) | Vesatolimod 10 or 12 mg (Cohort 6) | Placebo |
---|---|---|---|---|---|---|---|
![]() |
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing antiretroviral (ARV) regimen in accordance with their prescribing information (the following agents were allowed: nucleoside/nucleotide reverse transcriptase inhibitors [NRTIs], raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to Day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). |
Period Title: Overall Study | |||||||
Started | 6 | 6 | 6 | 6 | 6 | 6 | 12 |
Completed | 6 | 5 | 6 | 6 | 6 | 5 | 12 |
Not Completed | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Reason Not Completed | |||||||
Withdrew Consent | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Vesatolimod 1 mg (Cohort 1) | Vesatolimod 2 mg (Cohort 2) | Vesatolimod 4 mg (Cohort 3) | Vesatolimod 6 mg (Cohort 4) | Vesatolimod 8 mg (Cohort 5) | Vesatolimod 10 or 12 mg (Cohort 6) | Placebo | Total | |
---|---|---|---|---|---|---|---|---|---|
![]() |
Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 6 | 6 | 6 | 6 | 6 | 12 | 48 | |
![]() |
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
||||||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
44 (11.0) | 45 (10.7) | 52 (4.8) | 44 (9.3) | 45 (9.9) | 47 (17.5) | 45 (11.9) | 46 (10.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
Female | 0 | 1 | 0 | 0 | 3 | 1 | 0 | 5 | |
Male | 6 | 5 | 6 | 6 | 3 | 5 | 12 | 43 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
Hispanic or Latino | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 5 | |
Not Hispanic or Latino | 5 | 4 | 6 | 6 | 4 | 6 | 12 | 43 | |
Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
Black | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | |
White | 6 | 6 | 6 | 5 | 5 | 6 | 12 | 46 | |
HIV-1 RNA
Mean (Standard Deviation) Unit of measure: Log10 copies/mL |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
1.28 (0.000) | 1.28 (0.000) | 1.30 (0.062) | 1.28 (0.000) | 1.28 (0.000) | 1.28 (0.000) | 1.28 (0.000) | 1.28 (0.022) | ||
HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 48 participants | |
< 50 copies/ mL | 6 | 6 | 6 | 6 | 6 | 6 | 12 | 48 | |
≥ 50 copies/ mL | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |