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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported