Principal Investigator - Dr. Shahin Lockman MD, MPH
Study Objectives
Primary Objectives
- To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in sub-Saharan African women.
- To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in sub-Saharan African women.
Study Design: Multicenter, randomized, controlled, double-blind trial.
Study Population: Women in sub-Saharan Africa at risk of acquiring HIV through sexual transmission; 18 years to 40 years.
Study Size: 1924 total participants enrolled globally.
Study Duration: 60 months.
Sponsors
- Division of AIDS (DAIDS)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health (NIH)
- Department of Health and Human Services (DHHS) Bethesda, Maryland, USA
The first person joined the AMP study on May 17, 2016. The last person joined the study on September 20, 2018. 642 participants received the lower VRC01 dose of 10 mg/kg and 645 received the higher VRC01 dose of 30 mg/kg. 637 participants (33.1%) received the placebo. Overall, 16,805 IV infusions were given in the study. The overall adherence was 98% and 1,407 people got all ten of their scheduled infusions. The retention in the study was 96% prior to the restrictions of the COVID-19 pandemic. After March 15, 2020, retention dropped to 78%. Overall, 1,675 participants (about 87%) remained in the study through the final visit (24 months after enrollment).Participants were able to take VRC01 with little or no discomfort. When participants had side effects, they were usually mild to moderate and they lasted a few hours to a few days after the IV infusion. In the AMP studies, participants who got VRC01 were less likely to get HIV if they were exposed to the sensitive strains of HIV that were vulnerable to VRC01 and could be neutralized. But those who got VRC01 were not protected from getting HIV if they were exposed to the resistant HIV strains that VR0C01 was not able to neutralize.
