Table 2.
Toll-like receptor agonists and HIV: announced clinical trials in humans.
| ClinicalTrials.gov Identifier | Study Coordinators | Clinical Trial | Trial Phase | Status (as of 11 November 2022) |
|---|---|---|---|---|
| TLR agonists and broadly neutralizing monoclonal antibodies | ||||
| NCT05281510 | Gilead Sciences | A Phase 2a Study to Evaluate the Safety and Tolerability of a Regimen of Dual Anti-HIV Envelope Antibodies, VRC07-523LS and CAP256V2LS, in a Sequential Regimen With a TLR Agonist, Vesatolimod, in Early Antiretroviral-Treated HIV-1 Clade C-Infected Women | Phase 2a | Recruiting |
| NCT03837756 | University of Aarhus | Combining a TLR Agonist With Broadly Neutralizing Antibodies for Reservoir Reduction and Immunological Control of HIV Infection: An Investigator-initiated Randomised, Placebo-controlled, Phase IIa Trial. | Phase 2a | Active, not yet recruiting |
| Therapeutic vaccination and TLR agonist | ||||
| NCT04364035 | Aelix Therapeutics | Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection | Phase 2a | Active, not yet recruiting |
| NCT04177355 | National Institute of Allergy and Infectious Diseases (NIAID) | A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults | Phase 1 | recruiting |
| NCT04301154 | Henry M. Jackson Foundation for the Advancement of Military Medicine | Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth | Phase 1 | Recruiting |
| Active and passive immunisation with TLR agonist | ||||
| NCT04357821 | University of California, San Francisco | Combinatorial Therapy With a Therapeutic Conserved Element DNA Vaccine, MVA Vaccine Boost, TLR9 Agonist and Broadly Neutralizing Antibodies: a Proof-of-concept Study Aimed at Inducing an HIV Remission | Phase 1/phase 2 | Active, not yet recruiting |