NCT06508749

The Tatelo Plus Study

Phase I/II Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early Treated Children in Botswana

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 24 Weeks – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children.

Conditions

• HIV
• HIV Infections

Interventions

Type	Name	Description
DRUG	PGDM1400LS	IV Antibody Infusion based on subject's weight
DRUG	VRC07-523LS	IV Antibody Infusion based on subject's weight
DRUG	PGT121.414.LS	IV Antibody Infusion based on subject's weight
DRUG	ART Regimen prior to enrolling in Step 1a	Antiviral drugs are not study product. However, participants will continue to receive the ART regimen they were receiving prior to enrolling in the study during Step 1a.
DRUG	ART Regimen prior to enrolling in Step 1b	Antiviral drugs are not study product. However, participants will continue to receive the ART regimen they were receiving prior to enrolling in the study during Step 1b.
OTHER	Analytic Treatment Interruption	(all anti-HIV agents are discontinued)

Timeline

• Start date: 2024-11-11
• Primary completion: 2027-11-05
• Completion: 2028-04-21
• First posted: 2024-07-18
• Last updated: 2025-06-10

Locations

2 sites across 1 country: Botswana

Regulatory

• FDA-regulated drug study