Understanding the impact of HIV and treatment on young adults with perinatal HIV infection
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
This study looks at how living with HIV and taking treatment affects the long-term health of young adults who were born with the virus compared to those who weren't infected.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 820 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 14 sites (La Jolla, California and 13 other locations) |
| Trial ID | NCT02119702 on ClinicalTrials.gov |
What this trial studies
This observational study, known as AMP Up, focuses on young adults aged 18 and older who were perinatally infected with HIV, as well as a comparison group of uninfected individuals from similar backgrounds. The study aims to assess the long-term effects of HIV infection and antiretroviral therapy (ART) on various health outcomes, including infectious and non-infectious complications, metabolic health, reproductive health, and neurocognitive functioning. Participants will provide access to their medical records to track their health history and outcomes over time.
Who should consider this trial
Good fit: Ideal candidates include young adults aged 18 and older who have a documented history of perinatal HIV infection.
Not a fit: Patients who acquired HIV through means other than maternal-child transmission will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health challenges faced by young adults with perinatal HIV infection, leading to improved care strategies.
How similar studies have performed: Other studies have shown success in understanding the long-term effects of HIV and ART, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Perinatally HIV-Infected Cohort
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 this trial is running
La Jolla, California and 13 other locations
- University of California San Diego — La Jolla, California, United States (Recruiting)
- University of Colorado Denver Health Sciences Center — Aurora, Colorado, United States (Recruiting)
- Children's Diagnostic and Treatment Center — Fort Lauderdale, Florida, United States (Terminated)
- University of Miami — Miami, Florida, United States (Recruiting)
- Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States (Recruiting)
- Tulane University Health Sciences Center — New Orleans, Louisiana, United States (Recruiting)
- Children's Hospital Boston — Boston, Massachusetts, United States (Recruiting)
- Rutgers - New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
- Bronx Lebanon Hospital Center — Bronx, New York, United States (Recruiting)
- Jacobi Medical Center — Bronx, New York, United States (Recruiting)
- St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States (Recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- San Juan Research Hospital — San Juan, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Paige L Williams — Harvard School of Public Health (HSPH)
- Study coordinator: Liz Salomon, EdM
- Email: lsalomon@hsph.harvard.edu
- Phone: 617-432-6762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.