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RECRUITING
NCT06508749
PHASE1/PHASE2

The Tatelo Plus Study

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

24 Weeks - 25 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2024-11-11

Completion Date

2028-04-21

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

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)

Locations (2)

Francistown CRS (CRS #31891)

Francistown, Botswana

Botswana Harvard Health Partnership CRS (CRS #31833)

Gaborone, Botswana