Study Details

Protocol Status: Withdrawn
Study Purpose:

A phase 1, multi-site, randomized clinical trial to evaluate the safety, tolerability, antiviral activity, and pharmacokinetics of anti-HIV monoclonal antibodies VRC07-523LS and 10E8VLS administered by subcutaneous infusion with Hylenex and by intravenous infusion without Hylenex®, in healthy, HIV–uninfected adult participants

Study Design:

Multicenter, randomized, open-label trial

Study Population:

95 healthy, HIV–uninfected volunteers aged 18 to 50 years in the United States

Study Size:

95 healthy, HIV–uninfected volunteers aged 18 to 50 years

Study Duration:

Approximately 14 months; 23 total months including follow-up

Treatment Regimen:
Primary Objectives:

Primary objective 1:
To evaluate the safety and tolerability of VRC07-523LS and of 10E8VLS administered individually by subcutaneous (SC) infusion (with Hylenex)
To evaluate the safety and tolerability of VRC07-523LS and 10E8VLS administered sequentially by SC infusion (with Hylenex) and administered sequentially by intravenous (IV) infusion (without Hylenex)
Primary objective 2:
To evaluate the serum concentrations of VRC07-523LS and of 10E8VLS administered individually by SC infusion (with Hylenex)
To evaluate the serum concentrations of VRC07-523LS and 10E8VLS administered sequentially by SC infusion (with Hylenex) and administered sequentially by IV infusion (without Hylenex)
Primary objective 3:
To evaluate the individual mAb-specific serum neutralizing activity of VRC07-523LS and 10E8VLS

Key Study Personnel

Bonnie Dye, LOC Clinical Research Manager
Theresa Gamble, LOC Clinical Research Manager
Shelly Karuna, HVTN Clinical Trials Manager

Study Sites List