Health Trials

The Tatelo Plus Study

ConditionsHIVHIV Infections
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PGDM1400LS

    Drug

    IV Antibody Infusion based on subject's weight

  • VRC07-523LS

    Drug

    IV Antibody Infusion based on subject's weight

  • PGT121.414.LS

    Drug

    IV Antibody Infusion based on subject's weight

  • ART Regimen prior to enrolling in Step 1a

    Drug

    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.

  • ART Regimen prior to enrolling in Step 1b

    Drug

    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.

  • Analytic Treatment Interruption

    Other intervention

    (all anti-HIV agents are discontinued)

Treatment groups

41 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Group 1-Step 1a EntryExperimental treatment 4 interventions
Group B: Group 2-Step 1a EntryExperimental treatment 4 interventions
Group C: Step 1b EntryExperimental treatment 4 interventions
Group D: Step 2aExperimental treatment 3 interventions
Group E: Step 2bExperimental treatment 3 interventions
Group F: Step 3 progressionExperimental treatment 1 intervention
Group G: Group 3- Step 3 Direct EntryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To describe the safety and pharmacokinetics of bNAb immunotherapy with VRC07-523LS, PGDM1400LS and PGT121.414.LS when added to existing effective ART in early-treated children living with HIV-1 in Botswana

Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events Occurrence of any SAE Permanent discontinuation of study product Pre-dose trough concentrations of VRC07-523LS, PGDM1400LS and PGT121.414.LS at Week 16 Pre-dose trough concentrations of VRC07-523LS, PGDM1400LS and PGT121.414.LS through 32 weeks

Time frame
Through week 32
2

To describe the safety of up to 24 weeks of bNAb immunotherapy with VRC07-523LS, PGDM1400LS and PGT121.414.LS when added on a rotating schedule to existing effective ART in early-treated children living with HIV-1 in Botswana

Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events Occurrence of any SAE Permanent discontinuation of study product

Time frame
Through week 24
3

To determine the safety of 24 weeks of maintenance VRC07-523LS, PGDM1400LS and PGT121.414.LS immunotherapy alone, following the discontinuation of ART

Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events

Time frame
Through Week 24
4

To determine the maintenance of virologic suppression of 24 weeks of maintenance VRC07-523LS, PGDM1400LS and PGT121.414.LS immunotherapy alone, following the discontinuation of ART

Viral rebound defined as plasma HIV-1 RNA ≥400 copies/mL at or prior to 24 weeks of bNAb-only treatment.

Time frame
Through Week 24

Secondary outcomes

1

To measure the proportion of participants with viral rebound defined as a single plasma HIV-1 RNA ≥400 copies/mL at or prior to 48 weeks of bNAb-only treatment (for those who continue bNAb-only treatment beyond 24 weeks)

Viral rebound defined as plasma HIV-1 RNA ≥400 copies/mL at or prior to 48 weeks of bNAb-only treatment (among participants who continue beyond 24 weeks on bNAb-only treatment)

Time frame
Through week 48
2

To monitor and report time to re-suppression of plasma HIV-1 RNA following re-initiation of ART, for participants who experience viral rebound on bNAbs alone or during ATI

Time to viral re-suppression defined as first HIV-1 RNA \<40 copies/mL following ART resumption

Time frame
Through week 48
3

To measure the size of residual viral reservoirs, during each step of the study. Comparisons will include change during triple bNAbs + ART; change during triple bNAbs alone; change during ATI; and change during entire study

Change in total, intact, and defective provirus between entry and end of triple bNAbs + ART Change in total, intact, and defective provirus between start of bNAb-only treatment and end of bNAb-only treatment Change in total, intact, and defective provirus between start of ATI and end of ATI. Change in total, intact, and defective provirus between study entry and end of ATI.

Time frame
Through week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Source ClinicalTrials.gov
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