PedMAb1

Phase 1

Recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR202205715278722
• Lead Sponsor: South African Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-21
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Mother
• 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.

Newborn
• 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

Mother
• 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

Newborn
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified