CompletedPhase 1/2

Dual bNAb Treatment in Children

Botswana30 participantsStarted 2019-06-17

Plain-language summary

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.

Who can participate

Age range

96 Weeks – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: Measured through Week 24 of Step 2

Trial details

NCT IDNCT03707977

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-12-03

Results submitted2022-12-02

View on ClinicalTrials.gov More HIV Infection trials

Who can participate

Age range

96 Weeks – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: Measured through Week 24 of Step 2