HIV/AIDS
Conditions
Interventions
Experimental
Sponsors
National Institute of Allergy and Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Birthing parent is of legal age or circumstance to provide independent informed consent Birthing parent has confirmed HIV-1 infection Infant was singleton or twin Infant’s gestational age at birth was at least 36 weeks. At birth, infant’s weight was at least 2 kg. At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth. At entry, infant is generally healthy as determined by the site investigator Cohorts 1 and 2, Strata BF, only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding. At entry, infant is at increased risk of HIV acquisition
Exclusion criteria
Exclusion criteria: Birthing parent has received any investigational product during this pregnancy. Infant has received any active or passive HIV immunotherapy or any investigational product. At entry, infant with a documented positive HIV NAT result. Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety-Any Grade 3 or higher events through week 12 for those who will receive one dose, and through week 24 for those who will receive 2 doses, ;Pharmacologic-Maximum concentration (Cmax), time of maximum concentration (Tmax) Area under the curve (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety-For secondary safety outcome measures involving study product injection site local reactions, the number and proportion (two-sided exact 90% CI) of participants who experience each event will be summarized separately for one SC dose of PGT121.414.LS alone (Cohort 1, Strata FF and BF), two SC doses of PGT121.414.LS alone (Cohort 1, Stratum BF), one SC dose of PGT121.414.LS in combination with VRC07-523LS (Cohort 2, Strata FF and BF), and two SC doses of PGT121.414.LS in combination with VRC07-523LS (Cohort 2, Stratum BF). For one SC dose of PGT121.414.LS alone and one SC dose of PGT121.414.LS in combination with VRC07-523LS, event rates will also be summarized by stratum. The maximum grade, size, and duration of local reactions will also be summarized. This are immediate post intervention reactions;Pharmacologic-AUC0-48WK and concentration at Week 48 after single dose administration and concentration at Week 60 after two dose administration and Apparent clearance (CL/F), and half-life (T1/2) This is a post intervention outcome.;Antibodies-All participants who receive applicable study product and have available data at a time point of interest (e.g., Week 24 or Week 48) will be included in antibody analyses at a given time point corresponding to a study product. The number and proportion (two-sided exact 90% CI) of participants who develop anti-PGT121.414.LS and anti-VRC07-523LS (Cohort 2 only) antibodies will be summarized in aggregate and for each cohort-stratum combination. ;HIV Infection-All participants who receive any study product and do not have a positive HIV NAT based on a sample collected prior to study product administration will be included in HIV diagnosis analyses. The number and proportion (two-sided exact 90% CI) of participants with HIV diagnosis whose initial positive HIV NAT was based on a sample collected following study product administration will be summarized for each cohort-stratum combination. | — |
Countries
Kenya
Contacts
Public ContactCHARLES KILEL
Kenya Medical Research Institute Walter Reed Project Clinical Research Center
Outcome results
None listed