Evaluating the Safety and Pharmacokinetics of VRC01, A Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1 Exposed Infants

Official Title: Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, a Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1 Exposed Infants

<p>VRC01 and VRC01LS are anti-HIV neutralizing monoclonal antibodies that may help prevent mother-to-child transmission of HIV. This study will enroll HIV-infected mothers who are at increased risk of passing HIV on to their children. The purpose of this study is to assess the safety and PK of VRC01 and VRC01LS in HIV-exposed infants.</p> <p>This study will enroll mother-infant pairs into four groups. Infants enrolled in Dose Group 1 and Dose Group 2 will receive a single VRC01 injection less than 72 hours after birth. Infants in Dose Group 3 will receive a VRC01 injection less than 5 days after birth. They will then receive additional VRC01 injections monthly for at least 6 months and no more than 18 months while breastfeeding. Infants will enroll into one of two cohorts in Dose Group 4: Cohort 1 (non-breastfeeding) or Cohort 2 (breastfeeding). Infants in Cohort 1 will receive a single VRC01LS injection less than 72 hours after birth. Infants in Cohort 2 will receive an initial VRC01LS injection less than 5 days after birth, and a second VRC01LS injection at Week 12 if they are still breastfeeding.</p> <p>The mothers will not receive any VRC01 or VRC01LS injections. At study entry, all mothers will undergo a medical history review and a blood collection. Infants in Dose Groups 1 and 2 will attend several study visits through Week 48. Infants in Dose Group 3 and 4 will attend several study visits through Week 96. Visits will include a medical history review, physical examination, blood collection, and oral fluid collection</p>

NCT02256631
Chadwick, Ellen G., MD
Interventional
Yes

Contact Information:

Margaret Sanders, MPH

CRC

773-227-8275