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Could antibody shots replace daily HIV pills for kids?

NCT ID NCT03707977

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether two lab-made antibodies, VRC01LS and 10-1074, could keep HIV under control in 30 children in Botswana who started treatment early. The children received the antibodies by infusion and stopped their regular HIV medication. Researchers monitored how many kids maintained low virus levels and tracked any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VRC01LS and 10-1074 (broadly neutralizing antibodies)
What this could lead to
If successful, this could point toward a way for children with HIV to maintain viral suppression without daily antiretroviral therapy.
What could go wrong
This is an early-phase study with only 30 children, so results may not apply widely. The antibodies may not keep HIV suppressed in all children, and there is a risk of side effects from the infusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Jun 2019

Finished

Dec 2021

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

96 weeks to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infection

Contacts and locations

Locations

  • Botswana Harvard AIDS Institute Partnership CRS Non-Network

    Gaborone, Botswana

  • Francistown Non-Network CRS

    Francistown, Botswana

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