NCT03208231View on ClinicalTrials.gov

Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 6, 2018

Primary Completion Date

June 16, 2020

Study Completion Date

February 11, 2021

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC01

40 mg/kg of VRC01 administered by subcutaneous injection.

DRUG

Combination Antiretroviral Therapy (cART)

All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).

Trial Locations (7)

Unknown

Molepolole CRS, Molepolole

Gaborone CRS, Gaborone

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

Malawi CRS, Lilongwe

Blantyre CRS, Blantyre

Harare Family Care CRS, Harare

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03208231 - Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy | Biotech Hunter | Biotech Hunter