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

President and Fellows of Harvard College

Status: Completed

Conditions: HIV/AIDS

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03279185

1P01HD103133 (U.S. NIH Grant/Contract)

1P01HD103133 - PH400

PH400 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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:

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.

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

334 participants in 1 patient group

Infected Cohort - closed to accrual

Description:

Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.