RecruitingPhase 1Phase 2NCT06508749

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

41 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections HIV

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.

Eligibility

Min Age: 24 WeeksMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

The Tatelo Plus Study is following infants and young children living with HIV who are receiving antiretroviral therapy (ART) to look at the safety and effectiveness of their HIV treatment regimens over time. This study builds on prior HIV research cohorts in sub-Saharan Africa. **You may be eligible if...** - You (or your child) were previously enrolled in the Tatelo, EIT, or Moso HIV research study - The child is between 24 weeks and 12 years old at the time of enrollment - The child has been receiving prescribed HIV treatment (ART) for at least 24 weeks - The child's HIV viral load is suppressed (below 40 copies/mL or below 200 copies/mL depending on the step) **You may NOT be eligible if...** - The child has not been receiving ART for at least 24 weeks - The child does not meet viral suppression criteria - The child is not within the eligible age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPGDM1400LS

IV Antibody Infusion based on subject's weight

DRUGVRC07-523LS

IV Antibody Infusion based on subject's weight

DRUGPGT121.414.LS

IV Antibody Infusion based on subject's weight

DRUGART 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.

DRUGART 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.

OTHERAnalytic 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06508749

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