Auditory Research in Children Living With HIV Exposure-uninfected (ARCHIVE) (NCT06635642) | Clinical Trial Compass
WithdrawnNot Applicable
Auditory Research in Children Living With HIV Exposure-uninfected (ARCHIVE)
Stopped: Did not receive funding
0Started 2026-01-01
Plain-language summary
To evaluate the association of in utero antiretroviral therapy (ART) exposure and hearing abilities of children who were perinatally HIV-exposed, but HIV-free, stratified by timing of maternal ART initiation.
Who can participate
Age range
7 Years – 9 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:
* Healthy infants with delivery at \>36 weeks gestation age
* Birth weight \>2500g
* No major chromosomal anomalies, neural tube defects, seizures, HIV infection or other medical conditions that influenced neurodevelopmental outcomes and/or confounded the effects of ART and HIV exposure.
Exclusion Criteria:
* Child being older than the proposed age range
* Caregiver's or the child's refusal to participate
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.
1Since this trial has been withdrawn and is no longer recruiting, can you tell me if there are any similar studies looking at hearing or auditory processing in children who were exposed to HIV before birth that we could consider instead?
2This study was focused on 'dichotic digits performance,' which measures how the brain processes sounds heard in both ears at once — is this type of auditory processing testing something my child should be evaluated for outside of a clinical trial, given their HIV-exposure history?
3Because the trial never got off the ground, there's no safety or outcome data from it — does that change how you would approach monitoring my child's hearing development, and what standard-of-care options exist right now?
4Are there any other research centers or ongoing studies that are actively enrolling children with HIV exposure to look at hearing or central auditory processing, since this particular trial was withdrawn before it started?
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.