Clinical trial NCT01418014: Adolescent Master Protocol
Official title: Adolescent Master Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Mental Health (NIMH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Tulane University School of Medicine
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: NIH Office of AIDS Research (OAR)
First posted: 2011-08-16
Enrollment: 678
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected and -uninfected children from 7 years of age (7th birthday) up to but not including the 16th birthday at the time of enrollment born to HIV-infected mothers. Participants will be children previously enrolled in any of the studies included on the list of approved studies for co-enrollment (see below) or has medical record documentation since birth of key medical data related to their HIV infection.

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 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).

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 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Abnormal growth
timeFrame: Annually for 10 years
measure: Delayed sexual maturation
timeFrame: Annually for 10 years except if subject reaches Tanner Stage 5
measure: Abnormal bone mineral density
timeFrame: Two DXAs, two years apart, per HIV-infected subject; one DXA per uninfected subject; X-ray at same time as DXA unless subject Tanner Stage 5
measure: Dyslipidemia
timeFrame: Annually for 10 years
measure: Cardiac abnormalities
timeFrame: Measured once per subject until study reached 400 echocardiograms
measure: Hearing dysfunction
timeFrame: Once per subject.
measure: Language dysfunction
timeFrame: Annually for 10 years
measure: Neurodevelopmental abnormalities
timeFrame: Annually for 10 years
measure: Substance Use
timeFrame: Annually starting at a minimum of 10 years of age for 10 years
measure: Sexual Activity
timeFrame: Annually starting at a minimum of 10 years of age for 10 years
measure: Pregnancy
timeFrame: Annually for 10 years
measure: Sexually Transmitted Infection
timeFrame: Annually for 10 years
measure: Mitochondrial dysfunction
timeFrame: Annually for 10 years
measure: Lactic acidosis
timeFrame: Annually for 10 years
measure: Renal abnormalities
timeFrame: Annually for 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Health Sciences Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School
state: New Jersey
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Juan
country: Puerto Rico
facility: San Juan Research Hospital
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Paige L Williams
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University School of Medicine
name: Russell Van Dyke, M.D.
role: PRINCIPAL_INVESTIGATOR
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