HIV-exposed UninfectedHIV HEREDITYNCT04132830
HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
An observational study of HIV-exposed Uninfected, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-exposed Uninfected
- What is being tested?
- In Utero HIV Exposure and No In Utero HIV Exposure
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 26 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are recruiting mothers who had HIV during pregnancy and their HIV-negative young adult offspring (18-35 years old). We are also recruiting mothers and their young adult offspring without HIV to serve as controls.
Who may be able to join
- HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads
- Male or female young adult, 18-35 years old
- Documentation of HIV infection in mother with date of diagnosis preceding young adult birth date
- Negative HIV test in young adult
- Control Mother-Young Adult Dyads
- Matching to HEU dyad
- Negative HIV test in mother and young adult
Who cannot join
- All Young Adults
- Pregnancy within 6 months or active nursing
- Change in blood glucose or blood pressure medication within 3 months
- Change in estrogen or testosterone therapy within 3 months
- Chronic glucocorticoids (except steroid inhalers or creams) within 3 months
- Antiretroviral therapy use within 6 months (i.e., prophylaxis)
- Significant chronic illness judged by the investigator to represent a contraindication to participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.
- Conditions
- HIV-exposed Uninfected
- Being tested
- In Utero HIV Exposure, No In Utero HIV Exposure
- Keywords
- HIV-exposed Uninfected, In Utero Exposure, Metabolic, Immune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Utero HIV ExposureOther
Born to mother who had HIV infection during pregnancy.
No In Utero HIV ExposureOther
Born to mother who did not have HIV infection during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| HIV-Exposed Uninfected Dyads | Mothers who had HIV during pregnancy and their HIV-negative young adult offspring Receives: Other: In Utero HIV Exposure | |
| HIV-Unexposed Uninfected Dyads | Mothers and young adults without HIV Receives: Other: No In Utero HIV Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Measured: Baseline
Activated CD8+ T cells
Flow cytometry
Measured: Baseline
Secondary outcomes (10)
Abdominal fat mass
Dual-energy x-ray absorptiometry
Measured: Baseline
Glucose tolerance
Oral glucose tolerance test
Measured: Baseline
Lipids
Standard lipid panel (including HDL, triglycerides)
Measured: Baseline
Blood pressure
Systolic and diastolic
Measured: Baseline
Hepatic fat content
Transient elastography
Measured: Baseline
Hepatic fibrosis
Transient elastography
Measured: Baseline
Immune cell subsets
Flow cytometry
Measured: Baseline
Inflammatory markers
ELISA
Measured: Baseline
Frequency of Asthma
Measured: Baseline, Ever
DNA methylation patterns
Epigenome-wide analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Oct 2019
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-exposed UninfectedStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cross-sectional
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Fourman, MD, Massachusetts General Hospital
- Investigators
- Lindsay T Fourman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132830
- Sponsor's protocol ID
- 2019P000629
- Acronym
- HIV HEREDITY
- Status last verified
- Sep 2024
- First submitted
- 7 Oct 2019
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
- ClinicalTrials.gov ID
- NCT04132830
- Acronym / sponsor ID
- HIV HEREDITY / 2019P000629
- Conditions
- HIV-exposed Uninfected
- Keywords
- HIV-exposed Uninfected, In Utero Exposure, Metabolic, Immune
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 21 Oct 2019 (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.
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-Exposed Uninfected Dyads | – | Other: In Utero HIV ExposureMothers who had HIV during pregnancy and their HIV-negative young adult offspring |
| HIV-Unexposed Uninfected Dyads | – | Other: No In Utero HIV ExposureMothers and young adults without HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are recruiting mothers who had HIV during pregnancy and their HIV-negative young adult offspring (18-35 years old). We are also recruiting mothers and their young adult offspring without HIV to serve as controls.
Key inclusion criteria (7 listed)
- HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads
- Male or female young adult, 18-35 years old
- Documentation of HIV infection in mother with date of diagnosis preceding young adult birth date
- Negative HIV test in young adult
- Control Mother-Young Adult Dyads
Key exclusion criteria (7 listed)
- All Young Adults
- Pregnancy within 6 months or active nursing
- Change in blood glucose or blood pressure medication within 3 months
- Change in estrogen or testosterone therapy within 3 months
- Chronic glucocorticoids (except steroid inhalers or creams) within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Utero HIV ExposureBorn to mother who had HIV infection during pregnancy. | Other | HIV-Exposed Uninfected Dyads |
| No In Utero HIV ExposureBorn to mother who did not have HIV infection during pregnancy. | Other | HIV-Unexposed Uninfected Dyads |
Primary outcome
Body mass index (BMI)
Time frame: Baseline
Activated CD8+ T cells
Time frame: Baseline
Flow cytometry
10 secondary outcomes
Abdominal fat mass
Time frame: Baseline
Glucose tolerance
Time frame: Baseline
Lipids
Time frame: Baseline
Blood pressure
Time frame: Baseline
Hepatic fat content
Time frame: Baseline
Hepatic fibrosis
Time frame: Baseline
Immune cell subsets
Time frame: Baseline
Inflammatory markers
Time frame: Baseline
Frequency of Asthma
Time frame: Baseline, Ever
DNA methylation patterns
Time frame: Baseline
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 23 Sep 2024.
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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.
Lindsay T Fourman, MD principal investigator
Massachusetts General Hospital
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-exposed Uninfected, run by Massachusetts General Hospital 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 7 inclusion and 7 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 23 Sep 2024. 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?
Body mass index (BMI) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.