Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:April 2014
End Date:July 2020
Contact:Liz Salomon, EdM
Email:lsalomon@hsph.harvard.edu
Phone:617-432-6762

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This is a prospective cohort study designed to define the impact of HIV infection and
antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition
into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a
similar sociodemographic background and age distribution will be enrolled for comparison.

AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young
adults with perinatal HIV infection as they transition into adulthood. A group of perinatally
HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and
age distribution will be enrolled for comparison.

The primary objectives of this study are:

- To identify infectious and non-infectious complications of HIV disease and toxicities
resulting from long-term ART, including disease progression, immune dysfunction, viral
resistance, end-organ disease, and mortality.

- To define the impact of HIV infection and ART on the long-term clinical outcomes of
young adults, including:

- Metabolic abnormalities and risk factors for cardiovascular disease, including
glucose and lipid metabolism, blood pressure, and body composition.

- Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae,
Trichomonas vaginalis, syphilis, human papillomavirus, genital warts and HSV) among
males and females, and cervical HPV-associated pre-cancers and cancers and
Mycoplasma genitalium and other vaginal microbiota among females.

- Reproductive health, fertility, and pregnancy outcomes including mother-to-child
transmission of HIV.

- To define the impact of perinatal HIV infection and ART on long-term neurocognitive and
behavioral health outcomes, including:

- Mental health and neurocognitive functioning.

- Health care behaviors, including adherence to ART, participation in health care
services, and transition to adult clinical care.

- Risk behaviors, including sexual behavior and substance use.

- Independent living skills, and vocational and education achievement necessary for
successful transition to adult functioning and quality of life.

Perinatally HIV-Infected Cohort

Inclusion Criteria:

- Perinatal HIV infection as documented in the medical record

- At or beyond their 18th birthday at the time of informed consent with no upper age
limit

- Engaged in medical care and medical records are available

- At least one of the following is true:

- Previously or currently enrolled in PHACS AMP, or

- Previously enrolled in any of the studies included on the list of approved
studies for enrollment into AMP Up, or

- Available medical record documentation since early childhood of:

- ART exposure history

- Opportunistic infection prophylaxis exposure history

- Viral load and CD4+ cell count history

- Major medical events history

- Willingness to participate and provide legal written consent

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

Perinatally HIV-Exposed, -Uninfected Cohort

Inclusion Criteria:

- Perinatally HIV-exposed, perinatally-uninfected as indicated in the medical record;
the PHEU participant may have horizontally-acquired HIV infection

- At or beyond their 18th birthday at the time of informed consent with no upper age
limit

- At least one of the following is true:

- Previously or currently enrolled in PHACS AMP, or

- Previously or currently enrolled in PHACS SMARTT

- Willingness to participate and provide legal written consent

Exclusion Criteria:

- Have confirmed perinatal HIV infection as documented in the medical record
We found this trial at
14
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: William Shearer, MD, PhD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1401 South Federal Highway
Fort Lauderdale, Florida 33301
Principal Investigator: Ana Puga, MD
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Katherine Knapp, MD
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Gwendolyn Scott, MD
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Philadelphia, Pennsylvania 19134
Principal Investigator: Janet Chen, MD
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Philadelphia, PA
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Aurora, Colorado 80045
Principal Investigator: Elizabeth McFarland, MD
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Boston, Massachusetts 02115
Principal Investigator: Sandra Burchett, MD
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Boston, MA
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Bronx, New York 10457
Principal Investigator: Murli Purswani, MD
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Principal Investigator: Andrew Wiznia, MD
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Bronx, NY
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Chicago, Illinois 60614
Principal Investigator: Ram Yogev, MD
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Chicago, IL
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Stephen Spector, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Principal Investigator: Margarita Silio, MD
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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New Orleans, LA
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Newark, New Jersey 07103
Principal Investigator: Arry Dieudonne, MD
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Newark, NJ
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San Juan, 00936
Principal Investigator: Midnela Acevedo Flores, MD
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San Juan,
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