PACTR202205715278722
Recruiting
Phase 1
Phase I study to determine Safety and Pharmacokinetics of subcutaneous administration of potent and broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed uninfected (HEU) neonates and infants.
South African Medical Research Council0 sites72 target enrollmentApril 21, 2022
ConditionsHIV/AIDS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- South African Medical Research Council
- Enrollment
- 72
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Greater than or equal to 18 years of age
- •Documented HIV\-1 infection
- •Breastfeeding at the time of consenting or willing to initiate breastfeeding in the immediate post partum period.
- •Able and willing to provide a signed informed consent form to participate in the study for herself and her infant.
- •Alive infant with a birth weight greater than or equal to 2\.0 kg and lower than or equal to 4\.0kg
- •Gestational age greater or equal to 36 weeks, assessed using birth Ballard Score (done up to 42 hours after birth)
- •Written consent of the one or both parents (according to South African regulation)
Exclusion Criteria
- •Prior participation in any HIV\-1 vaccine trial
- •Receipt of any other active or passive HIV immunotherapy or investigational product concurrently
- •Documented or suspected serious medical illness with fetal compromise or immediate life\-threatening condition (other than HIV\-infection as judged by the examining clinician)
- •Most recent CD4 count (within a time frame of \=6 months) under 350 cells/mm3
- •Mother not on ART
- •Unable or not willing to breastfeed
- •Active tubercolosis
- •COVID\-19 diagnosis in the past month
- •Plan to relocate in 1 year
- •Mother does not have her own cell phone
Outcomes
Primary Outcomes
Not specified
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