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Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Official title: Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to Adults During Early Acute HIV Infection
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2016-04
Completion Date
2021-03-15
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
VRC01
40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
Placebo for VRC01
Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Locations (5)
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, Kenya
National Institute for Medical Research (NIMR)-Mbeya Medical Research Center (MMRC) Non-Network CRS
Mbeya, Tanzania
SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS
Bangkok, Thailand
ECHO Center Non-Network CRS
Chon Buri, Thailand
Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda