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Search / Trial NCT06635642

Auditory Research in Children Living With HIV Exposure-uninfected (ARCHIVE)

Launched by SAN DIEGO STATE UNIVERSITY · Oct 8, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The ARCHIVE trial is studying how exposure to antiretroviral therapy (ART) during pregnancy affects the hearing abilities of children who were exposed to HIV but are not infected with the virus themselves. Researchers want to understand if the timing of when mothers start ART during their pregnancies plays a role in their children's hearing. This study is important because it could help improve the health and development of children who were born to mothers living with HIV.

To participate in this trial, children must be healthy infants born after 36 weeks of pregnancy and weighing more than 5.5 pounds at birth. They should not have any major health issues that could affect their development, such as chromosomal disorders or HIV infection. The study is not currently recruiting participants, but when it starts, families who are interested in learning more about their child's hearing and development may find this trial valuable. Participants will likely undergo assessments of their hearing abilities, which can help researchers gather important information.

Gender

ALL

Eligibility criteria

  • 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

About San Diego State University

San Diego State University (SDSU) is a leading academic institution recognized for its commitment to research and innovation in various fields, including health sciences. With a robust infrastructure for clinical trials, SDSU engages in cutting-edge research aimed at advancing medical knowledge and improving patient care. The university fosters collaboration among interdisciplinary teams of researchers, clinicians, and students, enabling the development of novel therapeutic interventions and evidence-based practices. SDSU's dedication to ethical standards and rigorous scientific methodologies ensures that its clinical trials contribute valuable insights to the medical community and enhance public health outcomes.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported