Three long-acting HIV antibodies with planned ART breaks for early-treated children in Botswana
A Clinical Trial of Three Broadly Neutralizing Antibodies and Analytic Treatment Interruption in Early-Treated Children in Botswana
['FUNDING_U01'] · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · NIH-11398287
This offers three long-acting HIV-targeting antibodies to children who started HIV treatment early to see if they can safely take supervised breaks from daily ART.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH (nih funded) |
| Locations | 1 site (BOSTON, UNITED STATES) |
| Trial ID | NIH-11398287 on ClinicalTrials.gov |
What this research studies
You or your child would receive scheduled infusions of three long-acting broadly neutralizing antibodies (bNAbs) and be closely monitored instead of relying only on daily ART during planned, supervised treatment interruptions. The trial uses a step-wise design with an antibody rotation strategy and analytic treatment interruptions to observe whether viral suppression holds. Study staff will check viral load and immune markers frequently and restart ART if needed to protect health. This builds on a prior trial (Tatelo) that showed promising results with two bNAbs in early-treated children.
Who could benefit from this research
Good fit: Ideal candidates are children in Botswana who started ART early in life, are currently virally suppressed on ART, and meet the study's age and safety criteria.
Not a fit: Children who did not start ART early, who have unsuppressed viral loads, known resistance to these antibodies, or medical issues that make antibody therapy unsafe are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could allow children who began ART early to have safe periods off daily HIV pills, reducing drug side effects and easing adherence challenges.
How similar studies have performed: Earlier work (the Tatelo trial) showed monthly dual bNAbs maintained viral suppression off ART for 24 weeks in 44% of early-treated children, so this builds on promising but still early evidence.
Where this research is happening
BOSTON, UNITED STATES
- HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH — BOSTON, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SHAPIRO, ROGER L — HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- Study coordinator: SHAPIRO, ROGER L
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus