NCT03060447

Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers

A Phase 1b, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of GS-9620 in Antiretroviral Treated HIV-1 Infected Controllers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI) following vesatolimod dosing.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Vesatolimod	Tablets Administered orally
DRUG	Placebo	Tablets Administered orally
DRUG	ART	ART regimens administered in accordance with their prescribing information. The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc.

Timeline

• Start date: 2017-05-09
• Primary completion: 2020-02-13
• Completion: 2020-02-13
• First posted: 2017-02-23
• Last updated: 2021-04-21
• Results posted: 2021-04-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study