Status:
COMPLETED
Adolescent Master Protocol
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV/AIDS
Eligibility:
All Genders
7+ years
Brief Summary
The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent i...
Detailed Description
The primary objectives of AMP are: 1. To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social ...
Eligibility Criteria
Inclusion
- HIV-Infected Cohort
- Perinatal HIV infection as documented in the medical record.
- Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
- Engaged in care and ART history is available.
- Either: Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP as specified in the protocol. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols are listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history 2)Opportunistic Infection (OI) prophylaxis exposure history 3) Viral load and CD4 count history and 4) Major medical events history
- Willingness to participate and provide parental/legal guardian permission with assent. Children who do not know their HIV infection status will not be excluded.
- 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.
- HIV-Uninfected, HIV-Exposed Control Cohort
- Inclusion criteria:
- HIV-uninfected and born to an HIV-infected mother as documented in the medical record.
- Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
- Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols will be listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history and 2) Major medical events history.
- Willingness to participate and provide parental/legal guardian permission with assent.
Exclusion
- None.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT01418014
Start Date
March 1 2007
End Date
February 1 2021
Last Update
June 27 2025
Active Locations (15)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States, 80045
3
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
4
University of Miami
Miami, Florida, United States, 33136