Adolescent Master Protocol



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:7 - Any
Updated:9/12/2018
Start Date:March 2007
End Date:July 2020

Use our guide to learn which trials are right for you!

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).

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 development,
of pre-adolescents and adolescents with perinatal HIV infection as they move through
adolescence into adulthood.

2. To identify infectious and non-infectious complications of HIV disease, including the
toxicities of antiretroviral therapy (ART).

3. To investigate:

- Cognitive and behavioral changes over time, including medication adherence, family
and social function, and high risk behaviors such as risky sexual behavior, licit
and illicit drug use, and alcohol use;

- Changes in language and hearing;

- Changes in glucose metabolism, body composition, and bone mineralization;

- Changes in lipid metabolism and other risk factors for cardiovascular disease;

- Risk factors for secondary transmission of HIV; and

- The occurrence and clinical course of cervical HPV infections among females.

The domain-specific aims of AMP are:

1. Growth and sexual maturation: To longitudinally track growth and sexual maturation and
the factors that influence growth and maturation in HIV-infected children when compared
to HIV-exposed but uninfected children.

2. Metabolic risk factors for cardiovascular disease: To characterize the emergence of
abnormal glucose metabolism, lipid abnormalities, body composition and other risk
factors for cardiovascular disease and identify the contributing influences in
HIV-infected children when compared to HIV-exposed but uninfected children.

3. Cardiac function: To estimate the prevalence of cardiac structural and functional
abnormalities in HIV-infected children and youth when compared to HIV-exposed but
uninfected children.

4. Bone mineral density: To estimate the differences in bone mineral density of
HIV-infected children when compared to HIV-exposed but uninfected children and to
identify factors contributing to abnormal bone mineralization.

5. Neurologic, neurodevelopment, language, and behavioral function:

- To examine cognitive and behavioral outcomes of HIV-infected children and
adolescents, including high risk behaviors such as risky sexual behavior, licit and
illicit drug use, and alcohol use, neurodevelopmental impairment, school
achievement and to compare them with an HIV-exposed but uninfected control cohort.

- To examine non-adherence to antiretroviral therapy and predictors of non-adherence
among HIV-infected children receiving ART.

- To examine family and psychosocial factors associated with emotional and behavioral
problems.

6. Adolescent gynecology and STI infection:

- To evaluate the incidence of and risk factors for acquiring STIs/vaginal infections
(C. trachomatis, N. gonorrhea, T. vaginalis, syphilis, genital warts, HPV, and HSV)
for males and females, and in addition bacterial vaginosis for females.

- To evaluate the incidence, predictors, and outcomes of pregnancy.

HIV-Infected Cohort

Inclusion Criteria:

- 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. 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 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.
We found this trial at
15
sites
Philadelphia, Pennsylvania 19134
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1401 South Federal Highway
Fort Lauderdale, Florida 33301
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10457
?
mi
from
Bronx, NY
Click here to add this to my saved trials
1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
San Juan, 00936
?
mi
from
San Juan,
Click here to add this to my saved trials