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RECRUITINGPHASE1/PHASE2

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

NCT06508749•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.

Eligibility

Age

0 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Previously enrolled in the EIT/Tatelo, or Moso Cohort Study
•Receiving prescribed ART for at least 24 weeks prior to study entry as determined by the site investigator based on participant/parent/guardian report and available medical records
•24 weeks to 12 years of age at enrollment, inclusive
•If entering Step 1a: HIV-1 RNA \<40 copies/mL for at least 24 weeks prior to entry, including documented suppression to \<40 copies/mL within 30 days of Step 1 entry
•If entering Step 1b: HIV-1 RNA \<200 copies/mL for at least 24 weeks prior to entry, including documented suppression to \<40 copies/mL within 30 days of Step 1 entry.
•Normal temperature (\<37.4°C axillary, or \<38°C non-axillary) and no signs or symptoms of acute illness at entry as determined by the site investigator based on participant/parent/guardian report and available medical records
•Normal, grade 1 or grade 2 results for all of the following laboratory tests at screening, based on testing of specimens collected within 30 days prior to entry and grading per protocol:
•* Hemoglobin
•* Absolute neutrophil count
•* Platelet count
+13 more criteria

Exclusion Criteria

•3. No confirmed HIV-1 RNA ≥40 copies/mL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)
•4. Detection of \>80% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\>40 copies/mL) after this evaluation OR Negative EIA and negative Qualitative HIV DNA result within 12 weeks prior to Step 3 entry
•5. Approved for entry by Clinical Management Committee (CMC)
•6. Willingness and ability to provide independent written informed consent for participation or parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age
•If entering from Step 2:
•1. At or beyond the Week 24 visit of Step 2, with HIV-1 RNA \<40 copies/mL throughout Steps 1 and 2
•2. No confirmed HIV-1 RNA ≥40 copies/mL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)
•3. Negative EIA and negative qualitative DNA result within 12 weeks prior to Step 3 entry OR Detection of \>80% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\>40 copies/mL) after this evaluation entry AND approved for entry by CMC
•4. For Moso participants, not currently being breastfed
•5. Willingness and ability to provide independent written informed consent for participation or parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age
+29 more criteria

Locations (2)

Francistown CRS (CRS #31891)

Francistown, Botswana

Botswana Harvard Health Partnership CRS (CRS #31833)

Gaborone, Botswana

Key Dates

Start Date

November 11, 2024

Primary Completion Date

November 5, 2027

Completion Date

April 21, 2028

Last Updated

June 10, 2025

Enrollment

ESTIMATED participants

Conditions

HIVHIV Infections

Interventions

PGDM1400LS

DRUG

VRC07-523LS

DRUG

PGT121.414.LS

DRUG

ART Regimen prior to enrolling in Step 1a

DRUG

ART Regimen prior to enrolling in Step 1b

DRUG

Analytic Treatment Interruption

OTHER

Contacts

Molly Pretorius Holme, MSc

CONTACT

617-432-4377 mpretori@hsph.harvard.edu

Thinking and Memory Problems in People With HIV

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

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Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Tatelo Plus Study

Inclusion Criteria

Exclusion Criteria

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Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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