The Tatelo Plus Study
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age24-25
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Active tuberculosis (either suspected or proven) or malignancy.
Hepatitis B surface antigen (HBsAg) positive
Any immunoglobulin-based treatment
Chronic (more than 14 days) systemic steroid treatment
Trial design
Treatments tested in this trial
- PGDM1400LS
- VRC07-523LS
- PGT121.414.LS
- ART Regimen prior to enrolling in Step 1a
- ART Regimen prior to enrolling in Step 1b
- Analytic Treatment Interruption
Treatment groups
41 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov