HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Intravenous infusion (IV)
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Alabama CRA (Site #31788)
Birmingham, Alabama, United States
RECRUITINGBridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
RECRUITINGThe Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States
RECRUITINGBrigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
RECRUITINGFenway Health
Boston, Massachusetts, United States
RECRUITINGBIDMC VCRS (Site ID# 32077)
Boston, Massachusetts, United States
RECRUITINGColumbia P&S CRS
New York, New York, United States
RECRUITINGUniversity of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester, New York, United States
RECRUITINGChapel Hill CRS (Site #3201)
Chapel Hill, North Carolina, United States
RECRUITINGPenn Prevention CRS
Philadelphia, Pennsylvania, United States
RECRUITING...and 11 more locations
Number of participants experiencing local Adverse Events (AEs)
Time frame: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing local AEs
Time frame: At Days 1, 4, 7, 169 and 173
Number of participants experiencing systemic AEs
Time frame: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing systemic AEs
Time frame: At Days 1, 4, 7, 169 and 173
Number of participants experiencing unsolicited AEs
Time frame: Baseline through Week 48
Percentage of participants experiencing unsolicited AEs
Time frame: Baseline through Week 48
Number of participants experiencing Serious Adverse Events
Time frame: Baseline through Week 48
Number of participants who discontinue study product administration and terminate the study early
Time frame: Baseline through Week 48
Percentage of participants who discontinue study product administration and terminate the study early
Time frame: Baseline through Week 48
Change from baseline in ALT
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in aspartate aminotransferase (AST)
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in alkaline phosphatase (Alk Phos)
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in creatinine
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in Complete Blood Count (CBC)
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Area under the curve (AUC) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Maximum concentration (C(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Time to C(max) (T(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Clearance (CL) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Volume of distribution (Vd) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Terminal elimination rate constant (λz) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Terminal half-life (T1/2) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Area under the magnitude-breadth curve (AUC-MB) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
Presence of antidrug antibodies (ADAs) for VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time frame: At Days 1, 169 and 337
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