Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Completed
Conditions studied: HIV/AIDS
In brief
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.
Key facts
- Study ID
- NCT02119702
- Run by
- Harvard School of Public Health (HSPH)
- People needed
- 818
- Starts
- 2014-04-01
- Expected to finish
- 2025-05-31
- Last updated by the study team
- 2025-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Perinatal HIV infection as documented in the medical record
- At or beyond their 18th birthday at the time of informed consent with no upper age limit
- Willing to provide access to existing medical records
- Available medical record documentation since early childhood of:
- ART exposure history
- Opportunistic infection prophylaxis exposure history
- Viral load and CD4+ cell count history
- Major medical events history
- Willingness to participate and provide legal written consent
You may not qualify if…
- HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record
- Uninfected Cohort
- Inclusion Criteria:
- Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
- At or beyond their 18th birthday at the time of informed consent with no upper age limit
- Willingness to participate and provide legal written consent
- Exclusion Criteria:
- Have confirmed perinatal HIV infection as documented in the medical record
Where it is running
- University of California San Diego — La Jolla, California, United States
- University of Colorado Denver Health Sciences Center — Aurora, Colorado, United States
- Children's Diagnostic and Treatment Center — Fort Lauderdale, Florida, United States
- University of Miami — Miami, Florida, United States
- Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
- Tulane University Health Sciences Center — New Orleans, Louisiana, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
- Rutgers - New Jersey Medical School — Newark, New Jersey, United States
- Bronx Lebanon Hospital Center — The Bronx, New York, United States
- Jacobi Medical Center — The Bronx, New York, United States
- St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Baylor College of Medicine — Houston, Texas, United States
- San Juan Research Hospital — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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