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COMPLETED
NCT02591420
PHASE1

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)

View on ClinicalTrials.gov

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

BIOLOGICAL

VRC01

40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

BIOLOGICAL

Placebo for VRC01

Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

DRUG

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