Dual antibody treatment to maintain HIV suppression in children treated soon after birth
Official title: A clinical trial to evaluate the impact of broadly neutralizing antibody VRC01 on HIV viral reservoir and maintenance of suppression in a cohort of early-treated children in Botswana
Funded at The Botswana Harvard Health Partnership · NIH-11415443 · Data updated 2026-11-12
Children who started HIV treatment right after birth receive two long-acting antibodies to help keep the virus suppressed without daily medication.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | The Botswana Harvard Health Partnership NIH-funded |
| Lab location | 1 site (Gaborone, Botswana) |
| Project start | February 20, 2018 |
| Project end | January 31, 2027 |
| Funding year | 2024 |
| Award (this year) | $645,735 |
| NIH project number | 7U01AI135940-08 |
| Project ID | NIH-11415443 on NIH RePORTER |
Who could benefit from this research
✓Could help
Virally suppressed HIV-positive children who began standard ART within 96 hours of birth, have completed at least 96 weeks of ART, and meet the study's virologic entry criteria.
✕Less likely to help
Children who started ART later, are not consistently virally suppressed, or have HIV strains resistant to these antibodies are unlikely to benefit.
What this research studies
This multi-site Phase I/II study gives two broadly neutralizing HIV antibodies (VRC01LS and 10-1074) to children who started ART within 96 hours of birth and are currently virally suppressed. Participants were recruited from the Early Infant Treatment cohort and must have completed at least 96 weeks of ART and meet virologic entry criteria. After initial PK and safety checks (single then dual antibody doses), children receive dual antibodies together with ART for at least 8 weeks, then continue on antibodies alone for up to 24 weeks before returning to ART and follow-up. The study measures how long viral suppression can be maintained off ART and monitors safety and immune changes.
Why it matters
Potential benefit: If successful, some children might maintain viral suppression for months without daily ART, reducing pill burden and long-term drug exposure.
How similar studies have gone: Broadly neutralizing antibody combinations have delayed viral rebound in some adult trials, but using dual bNAbs to replace ART in early-treated children is relatively novel.
Where this research is happening
-
The Botswana Harvard Health Partnership
Gaborone, Botswana Active
Researchers
- Principal investigator: Makhema, Joseph Moeketsi — The Botswana Harvard Health Partnership
- Study coordinator: Makhema, Joseph Moeketsi
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.