Adolescent Master Protocol

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).

Conditions

• HIV/AIDS

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Tulane University School of Medicine

  collaborator OTHER

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• NIH Office of AIDS Research (OAR)

  collaborator NIH

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Paige L Williams · Harvard School of Public Health (HSPH)

• Russell Van Dyke, M.D. · Tulane University School of Medicine

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2021-02-28

Completion

2021-02-28

Countries

• United States
• Puerto Rico

Study Locations