Actively Recruiting
The Tatelo Plus Study
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-12
41
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Tatelo Plus Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously enrolled in the EIT/Tatelo or Moso Cohort Study
- Receiving prescribed ART for at least 24 weeks before study entry
- Aged between 24 weeks and 12 years for Step 1 enrollment
- HIV-1 RNA less than 40 copies/mL for at least 24 weeks prior to Step 1a entry
- HIV-1 RNA less than 200 copies/mL for at least 24 weeks prior to Step 1b entry
- Normal body temperature and no signs of acute illness at entry
- Grade 1 or 2 normal lab results for hemoglobin, neutrophils, platelets, liver enzymes, and creatinine
- For females able to become pregnant, not pregnant based on recent testing
- Expected to comply with study visits and requirements
- Not currently in another investigational study during participation
- Parental/legal guardian consent and child assent (if aged 7-17 years) obtained
- At or beyond Week 24 visit in Step 1 for Step 2 entry
- Susceptible to at least 2 of the 3 bNAbs or negative HIV antibody and DNA tests
- No confirmed HIV-1 RNA 40 copies/mL or higher throughout Step 1 and 24 weeks prior
- Various specific criteria for Step 3 including age 96 weeks to 25 years, viral suppression history, and approval by Clinical Management Committee
- Previously entered study in Step 1 or Step 3 to enter Step 4
You will not qualify if you...
- Active tuberculosis or cancer
- Positive Hepatitis B surface antigen (HBsAg)
- Received immunoglobulin treatment or chronic systemic steroids within 30 days before entry
- Any other significant medical condition that makes study participation unsafe or would interfere with results
- Weight less than 5 kg or more than 115 kg for Steps 1 and 2
- Received NNRTI-based ART within 14 days before Step 3 entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Francistown CRS (CRS #31891)
Francistown, Botswana
Actively Recruiting
2
Botswana Harvard Health Partnership CRS (CRS #31833)
Gaborone, Botswana
Actively Recruiting
Research Team
M
Molly Pretorius Holme, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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