SAMBULELO, a phase II double blind randomised placebo-controlled clinical trial to evaluate the safety & pharmacokinetics of VRC07-523LS in breastfed HIV-exposed uninfected and HIV-infected neonates and infants in South Africa.
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202308483453792
- Lead Sponsor
- South African Medical ResearchCouncil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 129
Eligibility criteria
Maternal inclusion criteria
1) Documented HIV-1infection antenatally or at delivery and receiving ART as per national guidelines
2) Greater than or equal to18 years of age
3) Breastfeeding at the time of enrolment or willing to initiate breastfeeding in the immediate post-partum period
INFANT ELIGIBILITY CRITERIA
1) Gestational age greater or equal to36 weeks, assessed using dual methods of early sonar AND birth Ballard Score (done up to 42 hours after birth)
2) Birth weight greater than or equal to 2.0 kg and lower than or equal to 4.5kg
3) Written consent of one or both parents (according to South African regulation)
Mother exclusion criteria
1) Prior participation in anyHIV-1 vaccine trial
2) Receipt of another active or passive HIVimmunotherapy or investigational product concurrently
3) Documented or suspected serious medical illness with fatal compromise or immediate life-threatening condition (other than HIV-infection as judged by the examining clinician)
4) Unable or unwilling to provide a signed informed consent to participate to the study for herself and her infant
5) Known active tuberculosis or other opportunistic infection
6.Plan to relocate in 1 year or do not have a local address
7)Does not have her own cell phone
8)Not able to provide three alternate contact phone numbers
9) Multiple pregnancies, i.e. twins, triplets, quadruplets, etc.
10) Unwilling or unable to comply with the schedule of activity
Infant exclusion criteria
1) Receipt of or anticipated need for blood product, immunoglobulin, or immunosuppressive therapy. This includes infants who require hepatitis immunoglobulins (HBIG) but not infants who receive hepatitis Bvaccine in the new-born period
2)Documented or suspected serious medical or immediate life-threatening condition
3) Infant in ICU or high care requiring supplemental oxygen at time of bNAb dose
4) Known allergy to study drug or components
5) Baseline laboratory results on all neonates
-Hemoglobin level less than 12.0 g/dL- Platelet count less than 100,000cells/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 than1,250 cells/mm3
- Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase ALT) greater than or equal to 1.25 times the upper limit of age-adjusted normal
Infant: 0 Month-23Month
36 Week(s)
12 Month(s)
Both
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method