HIV/AIDS
Conditions
Interventions
Sponsors
South African Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 tuberculosis • 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 two 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety (adverse events) until day 28 after a single SC administration of one bNAb, tested at increasing doses within 96 hours of birth, in breastfeeding HEU neonates (arms 1 through 5).;To evaluate the safety (adverse events) until day 28 after two single SC administration of two bNAbs, tested at increasing doses within 96 hours of birth, in breastfeeding HEU neonates (arm 6).;To evaluate the safety (adverse events) until day 28 after two single SC administrations of two bNAbs, within 96 hours of birth and repeated at 3 months (arms 6b) in breastfeeding HEU neonates | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK profile up to 6 months of each single bNAb administered, alone or in combination, at different doses within 96 hours of birth in breastfeeding HEU neonates (arms 1 through 5).;To evaluate the PK profile up to 3 months of bNAbs administered in combination, at different doses within 96 hours of birth in breastfeeding HEU (arm 6).;To evaluate the PK profile up to 6 months of each bNAb, administered in combination, in breastfeeding HEU infants after a second administration at 3 months (arms 6/6b).;To assess safety (adverse events) up to 6 months after each single bNAb (arms 1 to 5) or up to 3 months after the first combined bNAb administration (arms 6) or up to 6 months after the second combined bNAb administration arm 6b | — |
Countries
South Africa
Contacts
Public ContactKerusha Chunderduri
Regulatory and Quality Coordinator
Outcome results
None listed