drugset / Trial / NCT02591420

Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection

NCT02591420

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

Drugs

EvaluationDrugModalityDoseRoute
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