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The Tatelo Plus Study

NCT06508749 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2027-11-05
Completion
2028-04-21
FDA Drug
Yes

Countries

  • Botswana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06508749 on ClinicalTrials.gov