NCT03837756

Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV

Combining a TLR9 Agonist With Broadly Neutralizing Antibodies for Reservoir Reduction and Immunological Control of HIV Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of lefitolimod and 3BNC117/10-1074 in HIV-1-infected individuals on ART and during ATI as intervention to reduce the HIV-1 reservoir

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Saline	Placebo
DRUG	Lefitolimod	A TLR9 agonist administered s.c. once weekly for 8 weeks.
DRUG	3BNC117 and 10-1074	Broadly neutralizing antibodies against HIV env administered two times with a 3 week interval.

Timeline

• Start date: 2019-05-06
• Primary completion: 2022-07-01
• Completion: 2023-05-01
• First posted: 2019-02-12
• Last updated: 2023-05-23

Locations

8 sites across 4 countries: United States, Australia, Denmark, Norway

Regulatory

• FDA-regulated drug study