drugset / Trial / NCT06430905

Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART

NCT06430905 ↗

Phase 1 Terminated 30 enrolled Hookipa Biotech GmbH
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART). The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection. The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV. This trial studies the safety, tolerability, and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV. Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment.

Timeline

Start
2024-07-01
Primary completion
2025-07-18
Completion
2025-07-18

Outcome

Outcome not reported

Stopped (Business): “business decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject HB-501 Unknown — Intramuscular
Subject HB-502 Unknown — Intramuscular