Trials / Completed
CompletedNCT02858401
Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vesatolimod | Tablet(s) administered orally once every 2 weeks |
| 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. |
Timeline
- Start date
- 2015-01-29
- Primary completion
- 2019-02-14
- Completion
- 2019-02-14
- First posted
- 2016-08-08
- Last updated
- 2020-02-21
- Results posted
- 2020-02-21
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02858401. Inclusion in this directory is not an endorsement.