Adolescent Master Protocol

Completed

Conditions studied: HIV/AIDS

In brief

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 improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensuring that most previously infected American children have survived and are approaching adolescence. In addition, the number of HIV-infected adolescents worldwide is growing substantially in both resource-poor countries and in countries with increasing levels of health care. Therefore, there is a global cohort of children who have been living with HIV infection since birth who are aging into adolescence. Little is definitively known about the impact of HIV infection and its treatment on the maturation process in these children. AMP is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation, metabolic risk factors for cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment, language, hearing and behavioral function, and sexually transmitted infections (STI).

Key facts

Study ID

NCT01418014

Run by

Harvard School of Public Health (HSPH)

People needed

678

Starts

2007-03-01

Expected to finish

2021-02-01

Last updated by the study team

2025-06-27

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 Criteria: None.

Where it is running

• University of California San Diego — La Jolla, California, United States
• University of Colorado Denver Health Sciences Center — Aurora, Colorado, United States
• Children's Diagnostic and Treatment Center — Fort Lauderdale, Florida, United States
• University of Miami — Miami, Florida, United States
• Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Rutgers - New Jersey Medical School — Newark, New Jersey, United States
• Bronx Lebanon Hospital Center — The Bronx, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• San Juan Research Hospital — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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