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NCT Number: NCT03279185

Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite

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 as they transition to adulthood.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

David Geffen School of Medicine at UCLA, Los Angeles, California, United States

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About this study

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 as they transition to adulthood.

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 suppression, 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 with perinatal HIV.
  • To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Willingness to provide access to existing medical records; and
  • Willingness to participate and provide legal consent

Exclusion criteria

  • Prisoner status

Treatment and study plan

Primary outcomes

  1. HIV Disease Progression

    Time frame: Annually for 6 years

    Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction.

  2. Metabolic Anomalies

    Time frame: Annually for 6 years

    Data will be collected by chart review, physical assessments, and laboratory evaluations.

  3. Sexually Transmitted Infections

    Time frame: Annually for 6 years

    Data collected through chart abstraction.

  4. Reproductive Health

    Time frame: Annually for 6 years

    Data collected through an online surveys and chart abstraction.

  5. Mental Health

    Time frame: Annually for 6 years.

    Data collected through an online survey and chart abstraction.

  6. ART Adherence

    Time frame: Annually for 6 years

    Data collected through an online survey.

  7. Risk Behaviors (Sexual and Substance Use)

    Time frame: Annually for 6 years

    Data collected through an online survey.

  8. Transition to Adult Functioning

    Time frame: Annually for 6 years.

    Data collected through an online survey.

  9. Hearing Dysfunction

    Time frame: Annually for 6 years.

    Data collected through an online survey and chart abstraction.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • NIH Office of AIDS Research (OAR)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Institute of Mental Health (NIMH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)

Acronym: AMP Up Lite

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2017
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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