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HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults (HIV HEREDITY)

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ClinicalTrials.gov Identifier: NCT04132830
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Lindsay Fourman, MD, Massachusetts General Hospital

Study Description
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Brief 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). 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.

Condition or disease
HIV-exposed Uninfected

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
HIV-Exposed Uninfected Dyads
Mothers who had HIV during pregnancy and their HIV-negative young adult offspring
HIV-Unexposed Uninfected Dyads
Mothers and young adults without HIV


Outcome Measures
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Primary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: Baseline ]
  2. Activated CD8+ T cells [ Time Frame: Baseline ]
    Flow cytometry


Secondary Outcome Measures :
  1. Abdominal fat mass [ Time Frame: Baseline ]
    Dual-energy x-ray absorptiometry

  2. Glucose tolerance [ Time Frame: Baseline ]
    Oral glucose tolerance test

  3. Lipids [ Time Frame: Baseline ]
    Standard lipid panel (including HDL, triglycerides)

  4. Blood pressure [ Time Frame: Baseline ]
    Systolic and diastolic

  5. Hepatic fat content [ Time Frame: Baseline ]
    Transient elastography

  6. Hepatic fibrosis [ Time Frame: Baseline ]
    Transient elastography

  7. Immune cell subsets [ Time Frame: Baseline ]
    Flow cytometry

  8. Inflammatory markers [ Time Frame: Baseline ]
    ELISA

  9. Frequency of Asthma [ Time Frame: Baseline, Ever ]
  10. DNA methylation patterns [ Time Frame: Baseline ]
    Epigenome-wide analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are recruiting mothers who had HIV during pregnancy and their HIV-negative young adult offspring (18-30 years old). We are also recruiting mothers and their young adult offspring without HIV to serve as controls.
Criteria

INCLUSION CRITERIA:

HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads

  1. Male or female young adult, 18-30 years old
  2. Documentation of HIV infection in mother with date of diagnosis preceding young adult birth date
  3. Negative HIV test in young adult

Control Mother-Young Adult Dyads

  1. Matching to HEU dyad
  2. Negative HIV test in mother and young adult

EXCLUSION CRITERIA:

All Young Adults

  1. History of being adopted
  2. Pregnancy within 6 months or active nursing
  3. Change in blood glucose or blood pressure medication within 3 months
  4. Change in estrogen or testosterone therapy within 3 months
  5. Glucocorticoids (except steroid inhalers or creams) within 3 months
  6. Antiretroviral therapy use within 6 months (i.e., prophylaxis)
Contacts and Locations
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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): NCT04132830


Contacts
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Contact: Lindsay T Fourman, MD 617-643-4590 LFourman@partners.org
Contact: Isabel Zheng 67-643-4420 IZheng@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lindsay T Fourman, MD    617-643-4590    LFourman@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Lindsay T Fourman, MD Massachusetts General Hospital
More Information
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Responsible Party: Lindsay Fourman, MD, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04132830    
Other Study ID Numbers: 2019P000629
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023

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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 Lindsay Fourman, MD, Massachusetts General Hospital:
HIV-exposed Uninfected
In Utero Exposure
Metabolic
Immune
Additional relevant MeSH terms:
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Metabolic Diseases