Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
NCT ID: NCT03279185
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
334 participants
OBSERVATIONAL
2017-11-01
2025-05-31
Brief Summary
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Detailed Description
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The primary objectives of this study are:
1. To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality.
2. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
3. To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infected Cohort - closed to accrual
Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* At or beyond their 18th birthday at the time of informed consent with no upper age limit;
* Willingness to provide access to existing medical records; and
* Willingness to participate and provide legal consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
NIH Office of AIDS Research (OAR)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Paige Williams
Senior Lecturer on Biostatistics
Principal Investigators
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Paige L Williams
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Katherine Tassiopoulos, DSc, MPH
Role: STUDY_CHAIR
Harvard School of Public Health (HSPH)
Russell B Van Dyke, MD
Role: STUDY_CHAIR
Tulane University School of Medicine
Locations
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University of Southern California
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Cook County Hospital Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
New York University School of Medicine
New York, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100.
Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
Related Links
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Pediatric HIV/AIDS Cohort Study
Other Identifiers
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PH400
Identifier Type: OTHER
Identifier Source: secondary_id
1P01HD103133 - PH400
Identifier Type: -
Identifier Source: org_study_id
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