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Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)

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ClinicalTrials.gov Identifier: NCT03279185
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH Office of AIDS Research (OAR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
George Seage, Harvard School of Public Health

Brief Summary:
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 to adulthood.

Condition or disease
HIV/AIDS

Detailed Description:

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 to adulthood.

The primary objectives of this study are:

  1. To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality.
  2. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
  3. To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Infected Cohort
Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.



Primary Outcome Measures :
  1. HIV Disease Progression [ Time Frame: Annually for 6 years ]
    Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction.

  2. Metabolic Anomalies [ Time Frame: Annually for 6 years ]
    Data will be collected by chart review, physical assessments, and laboratory evaluations.

  3. Sexually Transmitted Infections [ Time Frame: Annually for 6 years ]
    Data collected through chart abstraction.

  4. Reproductive Health [ Time Frame: Annually for 6 years ]
    Data collected through an online surveys and chart abstraction.

  5. Mental Health [ Time Frame: Annually for 6 years. ]
    Data collected through an online survey and chart abstraction.

  6. ART Adherence [ Time Frame: Annually for 6 years ]
    Data collected through an online survey.

  7. Risk Behaviors (Sexual and Substance Use) [ Time Frame: Annually for 6 years ]
    Data collected through an online survey.

  8. Transition to Adult Functioning [ Time Frame: Annually for 6 years. ]
    Data collected through an online survey.

  9. Hearing Dysfunction [ Time Frame: Annually for 6 years. ]
    Data collected through an online survey and chart abstraction.


Biospecimen Retention:   Samples With DNA
Serum, plasma, peripheral blood mononuclear cells (PBMCs)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.
Criteria

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;
  • Willingness to provide access to existing medical records; and
  • Willingness to participate and provide legal consent

Exclusion Criteria:

  • Prisoner status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279185


Contacts
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Contact: Liz Salomon, EdM 6174324567 lsalomon@hsph.harvard.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Mariam Davtyan, MPH    323-865-1566    mdavtyan@usc.edu   
Principal Investigator: Toinette Frederick, PhD         
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Michele Carter, RN    301-206-6369    mfcarter@mednet.ucla.edu   
Principal Investigator: Jaime Deville, MD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bridget Wynn, MPH    404-616-2213    bridget.wynn@emory.edu   
Principal Investigator: Rana Chakraborty, MD         
United States, Illinois
Rush University Cook County Hospital Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen McNichols, RN    312-572-4541    maureen_e_mcnichols@rush.edu   
Principal Investigator: Mariam Aziz, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Thuy Anderson, RN    443-287-8942    tander34@jhmi.edu   
Principal Investigator: Allison Agwu, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Debra McLaud, RN    617-414-5813    debra.mclaud@bmc.org   
Principal Investigator: Stephen Pelton, MD         
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Sandra Deygoo, MS, CCRP    212-263-5680    nagamah.deygoo@nyumc.org   
Principal Investigator: William Borkowsky, MD         
SUNY Stony Brook Recruiting
Stony Brook, New York, United States, 17794
Contact: Erin Infanzon    631-444-8832    erin.infanzon@stonybrookmedicine.edu   
Principal Investigator: Sharon Nachman, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98101
Contact: Amanda Robson, BS    206-884-1535    amanda.robson@seattlechildrens.org   
Principal Investigator: Ann Melvin, MD         
Sponsors and Collaborators
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH Office of AIDS Research (OAR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: George R Seage, ScD, MPH Harvard School of Public Health
Study Chair: Katherine Tassiopoulos, DSc, MPH Harvard School of Public Health
Study Chair: Russell B Van Dyke, MD Tulane University School of Medicine

Additional Information:
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Responsible Party: George Seage, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03279185     History of Changes
Other Study ID Numbers: PH400
PH400 ( Other Identifier: PHACS Protocol Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Seage, Harvard School of Public Health:
HIV/AIDS, perinatal HIV infection