drugset / Trial / NCT05275998
TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals
Non-randomizedSequentialOpen-labelTreatment
Summary
TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test various doses of the combination of the antibodies for safety and pharmacokinetics in suppressed subjects on cART. Once dosing is established based on safety and PK, the optimally dosed combinations will be assessed as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 24 weeks.
Timeline
- Start
- 2022-07-05
- Primary completion
- 2024-11-20
- Completion
- 2024-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMB-365 | Monoclonal antibody | 2400 mg | Intravenous |
| Subject | TMB-365 | Monoclonal antibody | 3200 mg | Intravenous |
| Subject | TMB-365 | Monoclonal antibody | 4800 mg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 2400 mg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 3200 mg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 4800 mg | Intravenous |