Study Objectives

Primary Objectives 

• To assess the following among HIV-1-infected infants: 
  • Safety of VRC01 administered with Combination Antiretroviral Therapy (cART) (cumulatively through Week 14) .
  • Effect of VRC01 on HIV-1 DNA concentrations in peripheral blood mononuclear cells (change from Week 0 to Week 14) 

Secondary Objectives 

• To assess the following among HIV-1-infected infants: 
  • Pharmacokinetics of VRC01 (through Week 16)

Study Design: A Phase I/II, multisite, two-arm, randomized, controlled, open-label study to evaluate the safety and antiviral activity of VRC01 among HIV-1-infected infants initiating cART within 12 weeks of birth.

Study Population

• Globally: approximately 68 infants.
• In Botswana: approximately 8 infants (Gaborone and Molepolole).

This study is conducted among up to 68 HIV-infected infants initiating cART within 12 weeks of birth across all the participating sites.

Study Duration: 2 years.

Sponsor

• National Institute of Allergy and Infectious Diseases (NIAID).
• The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).