HIV/AIDS Paediatrics
Conditions
Interventions
Analytical Treatment Interruption with autovaccination
Sponsors
Umkhuseli Innovation and Research Management
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Our proposal is to focus on a select group of children LWH: Aged >36m Initiated cART within 3 weeks of life Plasma viral loads (pVL) of 24m Absolute CD4 counts >750c/ul if aged 36-59m, >500c/ul if aged >60m All measures in previous 12m of total DNA loads undetectable or 40.0 Parent/guardian consent, assent as appropriate for age
Exclusion criteria
Exclusion criteria: Age 3wks Not enrolled in the Baby Cure Study Any plasma HIV RNA viral load >30c/ml within the 24m prior to enrolment Absolute CD4 count at enrolment 60m Any DNA load >20cpm pbmc or GX>40.0 in previous 12m Parent/guardian unwilling to give consent Any medical condition, in the opinion of the principal investigator, that would make participation in the study unsafe, complicate interpretation of study outcome data, or interfere with achieving the study objectives. Any child: o Showing evidence of failure to thrive o Diagnosed with tuberculosis (TB) o Exposed to a TB source case who has yet to be investigated o Still receiving TB preventive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. % ART-free virological control (pVL<30c/ml) at 24 weeks into ATI-1 vs ATI-2 ;VL setpoint at ATI-2 ;Safety of autovaccination with ATI | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral setpoint after ATI-2;Determine vaccinal effect of autovaccination: HIV-specific CD4+ and CD8+ T-cell responses ;Determine plasma viral load decay kinetics ;Determine proviral DNA levels (total and intact) ;Determine % ART-free virological control at 4wks and 12wks post ATI-1 ATI-2 ;Determine time to viral rebound pVL>30c/ml in ATI-1 vs ATI-2 ;Correlate HIV-specific T-cell responses immediately prior to ATI-2 with: Time to pVL>1000c/ml during ATI-2; % cART-free virological control at 4wk, 12wk and 24wk into ATI-2; Proviral HIV DNA load (total and intact) | — |
Countries
South Africa
Contacts
Public ContactGabriela Cromhout
Clinical Coordinator and Research Clinician University of KwaZuluNatal
Outcome results
None listed