Last updated on December 2019

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

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Brief description of study

The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in HIV-1-infected infants beginning combination antiretroviral therapy (cART).

Detailed Study Description

VRC01 is an experimental human immunoglobulin G1 (IgG1) monoclonal antibody. The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in HIV-1-infected infants initiating cART within 12 weeks of birth.

The infants will be randomly assigned to either receive VRC01 (Arm 1) or not receive VRC01 (Arm 2). Infants in Arm 1 will receive VRC01 at study entry (Week 0) and Weeks 2, 6, and 10. Infants in Arm 2 will receive no study product.

Participants will attend study visits at Weeks 1, 2, 3, 6, 7, 10, 11, 14, 16, 20, 24, 36, and 48. Visits will include physical examinations, blood and urine collection, and specimen collection.

Infants' mothers may optionally be enrolled in the study for one-time specimen collection for exploratory evaluations. Maternal study participation is not required for infant study participation.

Study duration is approximately two years. Accrual is expected to require approximately one year, and each infant will complete 48 weeks of follow-up.