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).
Study Findings

Study findings not published yet.