HIVNCT01656564
Clinical Outcomes of People Who Acquired HIV in Early Life
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2012to 8 Mar 2023
- 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: HIV infected young adults; Healthy volunteers
Who may be able to join
- HIV positive participants
- Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life
- Age greater than or equal to 18 years
- HIV negative controls
- HIV negative, documented by a negative ELISA
- Age greater than or equal to 18 years
Show all 19Show fewer
- Free of any major underlying medical disorder
- Not currently pregnant
- For Reproductive Health Sub-Study:
- HIV positive participants
- Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life
- Age greater than or equal to 18 years
- Capable of providing independent informed consent
- HIV negative controls
- HIV negative, verified by a negative ELISA
- Age greater than or equal to 18 years
- For Healthy Volunteer, Questionnaire Group only
- Age >=18 years
- No known history of HIV
Who cannot join
- Clinically significant condition or systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate this study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Clinical Outcomes in Persons With HIV Acquired Early in Life
Background:
- Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Researchers are interested in studying how HIV infection and the medicines used to treat it affect people who were infected early in life. They want to find out if there are any problems with how HIV-infected children grow and develop as adults, especially if they have developed heart problems. As part of this study, people with HIV will be compared with healthy volunteers.
Read more
Objectives:
- To study the effect of HIV infection and treatment on people who acquired HIV infection in early life.
Eligibility:
- Individuals at least 18 years of age who acquired HIV infection in early life.
- Healthy volunteers at least 18 years of age without HIV will serve as controls
Design:
- Participants will be screened with a physical exam and medical history. They will have regular study visits about once a year for up to 10 years to collect health information.
- Blood and urine samples will be collected to look at kidney and liver function.
- X-ray scans will be used to look at bone density and the amount of fat and muscle in the body.
- Treatment will not be provided as part of this study.
Read the detailed description
Background:
- Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
- Long-term survivors of pediatric HIV infection offer a tremendous opportunity to understand the effects of HIV and ART health outcomes.
- A thorough understanding of the impact of HIV and ART on these long-term processes is extremely relevant as ART programs for HIV-infected children expand globally.
Objective:
- To explore the clinical outcomes and the impact of HIV infection and ART on a cohort with HIV infection acquired in early life
Eligibility:
- Individuals at least 18 years of age who acquired HIV infection in early life
- Healthy volunteers without HIV (greater than or equal to 18 years of age) will serve as controls
Design:
- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted.
- Conditions
- HIV
- Keywords
- HIV, Childhood, Antiviral Therapy, Cardiac, Natural History
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 |
|---|---|---|
| Healthy Controls | Individuals with no known history of HIV | |
| Healthy Controls - Questionnaire Group | Individuals with no known history of HIV | |
| HIV | Individuals who acquired HIV in early life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status
vital status and health outcomes will be determined annually throughout the study
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study start27 Aug 2012
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Colleen M Hadigan, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656564
- Sponsor's protocol ID
- 120157
- Other IDs
- 12-I-0157
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2012
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: .This is not an interventional study. This is a natural history study. Results are provided in aggregate in the form of published journal articles.
Publications
Aepfelbacher JA, Chaudhury CS, Mee T, Purdy JB, Hawkins K, Curl KA, Dee N, Hadigan C. Reproductive and sexual health knowledge, experiences, and milestones in young adults with life-long HIV. AIDS Care. 2020 Mar;32(3):354-361. doi: 10.1080/09540121.2019.1679711. Epub 2019 Oct 22.
PubMed 31640401Abd-Elmoniem KZ, Ishaq H, Purdy J, Matta J, Hamimi A, Hannoush H, Hadigan C, Gharib AM. Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease-Risk Persons Living with HIV. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230102. doi: 10.1148/ryct.230102.
PubMed 38573125Sahagun SJ, Yeramosu T, Purdy JB, Reynolds JC, Hadigan CM. Associations Between Central Obesity and Lifelong Antiviral Therapy in Adults Living With HIV Acquired From Early Childhood. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):208-214. doi: 10.1097/QAI.0000000000002841.
PubMed 34693931Aepfelbacher JA, Balmaceda J, Purdy J, Mattingly A, Zambell K, Hawkins K, Chairez C, Curl KA, Dee N, Hadigan C. Increased Prevalence of Hepatic Steatosis in Young Adults With Lifelong HIV. J Infect Dis. 2019 Jun 19;220(2):266-269. doi: 10.1093/infdis/jiz096.
PubMed 30852587Unsal AB, Mattingly AS, Jones SE, Purdy JB, Reynolds JC, Kopp JB, Hazra R, Hadigan CM. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2896-2904. doi: 10.1210/jc.2017-00197.
PubMed 28531309Mattingly AS, Unsal AB, Purdy JB, Gharib AM, Rupert A, Kovacs JA, McAreavey D, Hazra R, Abd-Elmoniem KZ, Hadigan C. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults. Pediatr Infect Dis J. 2017 Jan;36(1):63-65. doi: 10.1097/INF.0000000000001354.
PubMed 27749650
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Persons With HIV Acquired Early in Life
- ClinicalTrials.gov ID
- NCT01656564
- Acronym / sponsor ID
- 120157
- Conditions
- HIV
- Keywords
- HIV, Childhood, Antiviral Therapy, Cardiac, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 27 Aug 2012 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 3 Aug 2012 (estimated)
- 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.
Background:
- Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Researchers are interested in studying how HIV infection and the medicines used to treat it affect people who were infected early in life. They want to find out if there are any problems with how HIV-infected children grow and develop as adults, especially if they have developed heart problems. As part of this study, people with HIV will be compared with healthy volunteers.
Objectives:
- To study the effect of HIV infection and treatment on people who acquired HIV infection in early life.
Eligibility:
- Individuals at least 18 years of age who acquired HIV infection in early life.
- Healthy volunteers at least 18 years of age without HIV will serve as controls
Design:
- Participants will be screened with a physical exam and medical history. They will have regular study visits about once a year for up to 10 years to collect health information.
- Blood and urine samples will be collected to look at kidney and liver function.
- X-ray scans will be used to look at bone density and the amount of fat and muscle in the body.
- Treatment will not be provided as part of this study.
Detailed description
Background:
- Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
- Long-term survivors of pediatric HIV infection offer a tremendous opportunity to understand the effects of HIV and ART health outcomes.
- A thorough understanding of the impact of HIV and ART on these long-term processes is extremely relevant as ART programs for HIV-infected children expand globally.
Objective:
- To explore the clinical outcomes and the impact of HIV infection and ART on a cohort with HIV infection acquired in early life
Eligibility:
- Individuals at least 18 years of age who acquired HIV infection in early life
- Healthy volunteers without HIV (greater than or equal to 18 years of age) will serve as controls
Design:
- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Individuals with no known history of HIV |
| Healthy Controls - Questionnaire Group | – | –Individuals with no known history of HIV |
| HIV | – | –Individuals who acquired HIV in early life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected young adults; Healthy volunteers
Key inclusion criteria (19 listed)
- HIV positive participants
- HIV negative controls
- HIV positive participants
- HIV negative controls
- For Healthy Volunteer, Questionnaire Group only
Key exclusion criteria (1 listed)
- Clinically significant condition or systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate this study
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
Health Status
Time frame: End of Study
vital status and health outcomes will be determined annually throughout the study
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 9 Mar 2023.
- Background: PubMed 31640401Aepfelbacher JA, Chaudhury CS, Mee T, Purdy JB, Hawkins K, Curl KA, Dee N, Hadigan C. Reproductive and sexual health knowledge, experiences, and milestones in young adults with life-long HIV. AIDS Care. 2020 Mar;32(3):354-361. doi: 10.1080/09540121.2019.1679711. Epub 2019 Oct 22.
- Derived from this study: PubMed 38573125Abd-Elmoniem KZ, Ishaq H, Purdy J, Matta J, Hamimi A, Hannoush H, Hadigan C, Gharib AM. Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease-Risk Persons Living with HIV. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230102. doi: 10.1148/ryct.230102.
- Derived from this study: PubMed 34693931Sahagun SJ, Yeramosu T, Purdy JB, Reynolds JC, Hadigan CM. Associations Between Central Obesity and Lifelong Antiviral Therapy in Adults Living With HIV Acquired From Early Childhood. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):208-214. doi: 10.1097/QAI.0000000000002841.
- Derived from this study: PubMed 30852587Aepfelbacher JA, Balmaceda J, Purdy J, Mattingly A, Zambell K, Hawkins K, Chairez C, Curl KA, Dee N, Hadigan C. Increased Prevalence of Hepatic Steatosis in Young Adults With Lifelong HIV. J Infect Dis. 2019 Jun 19;220(2):266-269. doi: 10.1093/infdis/jiz096.
- Derived from this study: PubMed 28531309Unsal AB, Mattingly AS, Jones SE, Purdy JB, Reynolds JC, Kopp JB, Hazra R, Hadigan CM. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2896-2904. doi: 10.1210/jc.2017-00197.
- Derived from this study: PubMed 27749650Mattingly AS, Unsal AB, Purdy JB, Gharib AM, Rupert A, Kovacs JA, McAreavey D, Hazra R, Abd-Elmoniem KZ, Hadigan C. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults. Pediatr Infect Dis J. 2017 Jan;36(1):63-65. doi: 10.1097/INF.0000000000001354.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. .This is not an interventional study. This is a natural history study. Results are provided in aggregate in the form of published journal articles.
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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.
Colleen M Hadigan, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 19 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Health Status (time frame: End of Study). 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 NCT01656564, which also lists 6 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 9 Mar 2023.