drugset / Trial / NCT02591420
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.
Timeline
- Start
- 2016-04
- Primary completion
- 2021-03-15
- Completion
- 2021-03-15
Outcome
Missed primary endpoint
registry analysis (superiority test); Group 1: Immediate ART and Placebo Infusion vs Group 2: Immediate ART and VRC01 Infusion; p = .645; Wilcoxon (Mann-Whitney) NCT02591420 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | VRC01 | Monoclonal antibody | 40 mg/kg | Intravenous |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |