Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Stephen Spector, MD

Description

Summary

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.

Details

AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of uninfected perinatally-exposed young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

The primary objectives of this study are:

  • To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune dysfunction, viral resistance, end-organ disease, and mortality.
  • To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults, including:
    • Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition.
    • Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis, human papillomavirus (HPV), genital warts and HSV) among males and females, and cervical HPV-associated pre-cancers and cancers and Mycoplasma genitalium and other vaginal microbiota among females.
    • Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV.
  • To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including:
    • Mental health and neurocognitive functioning.
    • Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care.
    • Risk behaviors, including sexual behavior and substance use.
    • Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.

Keywords

HIV/AIDS, HIV/AIDS, perinatal HIV infection, Acquired Immunodeficiency Syndrome, HIV Infections

Eligibility

For people ages 18 years and up

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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Colorado Denver Health Sciences Center accepting new patients
    Aurora Colorado 80045 United States

Lead Scientist at UCSD

  • Stephen Spector, MD
    Dr. Spector, a world leader in HIV research for more than 25 years, is Distinguished Professor of Pediatrics, the Chief of the Division of Pediatric Infectious Diseases and Director of the UCSD Mother-Child-Adolescent HIV Program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Harvard School of Public Health (HSPH)
Links
Pediatric HIV/AIDS Cohort Study
ID
NCT02119702
Study Type
Observational
Participants
Expecting 850 study participants
Last Updated