The Tatelo Plus Study

Recruiting now · Phase 1/Phase 2

Conditions studied: HIV, HIV Infections

In brief

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.

Key facts

Study ID

NCT06508749

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

41

Starts

2024-11-11

Expected to finish

2028-02-18

Last updated by the study team

2026-05-29

Who can join

Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Active tuberculosis (either suspected or proven) or malignancy.
• Hepatitis B surface antigen (HBsAg) positive
• Received within 30 days prior to study entry, or is identified as requiring, any of the following:
• Any immunoglobulin-based treatment
• Chronic (more than 14 days) systemic steroid treatment
• Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• For participants entering Step 1 and Step 2: <5 kg or >115kg.
• For participants entering Step 3 directly: Received NNRTI-based ART (including efavirenz, nevirapine, rilpivirine) within 14 days of Step 3 entry

Where it is running

• Francistown CRS (CRS #31891) — Francistown, Botswana (enrolling)
• Botswana Harvard Health Partnership CRS (CRS #31833) — Gaborone, Botswana (enrolling)

Full record on ClinicalTrials.gov

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