Clinical trial

A Clinical Trial to Evaluate the Impact of Broadly Neutralizing Antibodies VRC01LS and 10-1074 on Maintenance of HIV Suppression in a Cohort of Early-Treated Children in Botswana (Dual bNAb Treatment in Children)

Name

Tatelo Study

Description

The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.

Trial arms

Trial start

2019-06-17

Estimated PCD

2021-12-03

Trial end

2021-12-03

Status

Completed

Phase

Early phase I

Treatment

ART

ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.

Arms:

Group PK-A: ART + VRC01LS, Group PK-B: ART + 10-1074, Steps 1-3 Participants (ART + 10-1074 + VRC01LS)

VRC01LS

Administered by intravenous (IV) infusion

Arms:

Group PK-A: ART + VRC01LS, Steps 1-3 Participants (ART + 10-1074 + VRC01LS)

10-1074

Administered by intravenous (IV) infusion

Arms:

Group PK-B: ART + 10-1074, Steps 1-3 Participants (ART + 10-1074 + VRC01LS)

Size

Primary endpoint

Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade]

Measured until 30 days after study completion for each participant

Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)

Measured until 30 days after study completion for each participant

Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART

Measured through Week 24 of Step 2

Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART

Measured through Week 24 of Step 2

Eligibility criteria

Inclusion Criteria for PK Step\*: * On ART for at least 96 weeks * Greater than or equal to 96 weeks and less than 5 years of age at enrollment * HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry * Ability to remain in close study follow-up for at least 12 weeks * Willingness to receive IV infusions of bNAbs * Willingness to provide signed informed consent (by the parent/guardian) * \*It is anticipated that all children in PK Step will be from Early Infant Treatment (EIT) Study (NCT02369406); however, up to 4 HIV+ children outside the PK Study (age range 2-5 years) may participate in the PK Step if otherwise eligible and if EIT children are unavailable. Inclusion Criteria for Entry into Step 1 (followed by participation in Steps 2-3): * EIT Study participant (NCT02369406) * On ART for at least 96 weeks * Greater than or equal to 96 weeks and less than 7 years of age at enrollment * HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry * Ability to remain in close study follow-up for at least 56 weeks * Willingness to receive IV infusions of bNAbs * Willingness to provide signed informed consent (by the parent/guardian) Exclusion Criteria: * Medical condition making survival for at least 32 weeks unlikely * Active tuberculosis or malignancy * Actively breastfeeding * Previous receipt of VRC01/VRC01LS or 10-1074 (except during the PK Step)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2023-02-14

1 organization

3 products

1 indication

Organization

National Institute of Allergy and Infectious Diseases

Product

Indication

Product

Product