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Clinical Trials/PACTR202205715278722
PACTR202205715278722RecruitingPhase 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 enrollmentStarted: April 21, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Sponsor
Enrollment
72
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
0 Day(s) to 1 Month(s) (—)
Sex
Female

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
  • •Mother not able to provide three alternate contact phone numbers
  • •HIV-infected on birth PCR
  • •Receipt of or anticipated need for blood product, immunoglobulin or immunosuppressive therapy. This includes infants who require hepatitis B immunoglobulins (HBIG) but not infants who receive hepatitis B vaccine in the new-born period
  • •Documented or suspected serious medical or immediate life-threatening condition
  • •Infant in ICU or high care requiring supplemental oxygen at time of first bNAb dose
  • •Known allergy to study drug or components
  • •Multiple birth, i.e. twins, triplets, quadruplets, etc
  • •Baseline laboratory results:
  • •Haemoglobin level less than 12.0 g/dL
  • •Platelet count less than 100,000 cells/mm3
  • •Absolute neutrophil count: for infants less than 24 hours old, less than 4,000 cells/mm3; for infants greater than 24 hours old, less than 1,250 cells/mm3
  • •Serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT) greater than or equal to 1.25 times upper limit of age-adjusted normal.
  • •Serum bilirubin at a level needing phototherapy

Investigators

Sponsor
South African Medical Research Council

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