HIV/AIDSAMP Up LiteNCT03279185
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- How many people
- 334 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Nov 2017to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.
Who may be able to join
- 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
Who cannot join
- Prisoner status
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
Boston Medical Center
Boston, Massachusetts, 02118
Rush University Cook County Hospital Chicago
Chicago, Illinois, 60612
University of Southern California
Los Angeles, California, 90033
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
New York University School of Medicine
New York, New York, 10016
Seattle Children's Hospital
Seattle, Washington, 98101
SUNY Stony Brook
Stony Brook, New York, 17794
About this study
Official title: Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
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.
Read the 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:
- 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.
- To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
- To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, perinatal HIV infection
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infected Cohort - closed to accrual | Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Disease Progression
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.
Measured: Annually for 6 years
Metabolic Anomalies
Data will be collected by chart review, physical assessments, and laboratory evaluations.
Measured: Annually for 6 years
Sexually Transmitted Infections
Data collected through chart abstraction.
Measured: Annually for 6 years
Reproductive Health
Data collected through an online surveys and chart abstraction.
Measured: Annually for 6 years
Mental Health
Data collected through an online survey and chart abstraction.
Measured: Annually for 6 years.
ART Adherence
Data collected through an online survey.
Measured: Annually for 6 years
Risk Behaviors (Sexual and Substance Use)
Data collected through an online survey.
Measured: Annually for 6 years
Transition to Adult Functioning
Data collected through an online survey.
Measured: Annually for 6 years.
Hearing Dysfunction
Data collected through an online survey and chart abstraction.
Measured: Annually for 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Nov 2017
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- 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), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Paige Williams, Harvard School of Public Health (HSPH)
- Investigators
- Paige L Williams, Principal investigator, Harvard School of Public Health (HSPH)Katherine Tassiopoulos, DSc, MPH, Study chair, Harvard School of Public Health (HSPH)Russell B Van Dyke, MD, Study chair, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279185
- Sponsor's protocol ID
- 1P01HD103133 - PH400
- Other IDs
- PH400, 1P01HD103133
- Acronym
- AMP Up Lite
- Status last verified
- Jun 2025
- First submitted
- 22 Aug 2017
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100.
PubMed 36150048Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
PubMed 39411892
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite (AMP Up Lite)
- ClinicalTrials.gov ID
- NCT03279185
- Acronym / sponsor ID
- AMP Up Lite / 1P01HD103133 - PH400
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, perinatal HIV infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- 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), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
- To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infected Cohort - closed to accrual | – | –Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Prisoner status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Metabolic Anomalies
Time frame: Annually for 6 years
Data will be collected by chart review, physical assessments, and laboratory evaluations.
Sexually Transmitted Infections
Time frame: Annually for 6 years
Data collected through chart abstraction.
Reproductive Health
Time frame: Annually for 6 years
Data collected through an online surveys and chart abstraction.
Mental Health
Time frame: Annually for 6 years.
Data collected through an online survey and chart abstraction.
ART Adherence
Time frame: Annually for 6 years
Data collected through an online survey.
Risk Behaviors (Sexual and Substance Use)
Time frame: Annually for 6 years
Data collected through an online survey.
Transition to Adult Functioning
Time frame: Annually for 6 years.
Data collected through an online survey.
Hearing Dysfunction
Time frame: Annually for 6 years.
Data collected through an online survey and chart abstraction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Results publication: PubMed 36150048Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100.
- Results publication: PubMed 39411892Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
- Pediatric HIV/AIDS Cohort StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paige L Williams principal investigator
Harvard School of Public Health (HSPH)
Katherine Tassiopoulos, DSc, MPH study chair
Harvard School of Public Health (HSPH)
Russell B Van Dyke, MD study chair
Tulane University School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Disease Progression (time frame: Annually for 6 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279185, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.