drugset / Trial / NCT02858401
Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-01-29
- Primary completion
- 2019-02-14
- Completion
- 2019-02-14
Publications
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vesatolimod | Small molecule | 1 mg | Oral |
| Subject | Vesatolimod | Small molecule | 2 mg | Oral |
| Subject | Vesatolimod | Small molecule | 4 mg | Oral |
| Subject | Vesatolimod | Small molecule | 6 mg | Oral |
| Subject | Vesatolimod | Small molecule | 8 mg | Oral |
| Subject | Vesatolimod | Small molecule | 12 mg | Oral |