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OpenTrials
Completed

NCT Number: NCT04132830

HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults

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.

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Key information

Conditions

HIV-exposed Uninfected

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

In Utero HIV Exposure

Other

Born to mother who had HIV infection during pregnancy.

No In Utero HIV Exposure

Other

Born to mother who did not have HIV infection during pregnancy.

Primary outcomes

  1. Body mass index (BMI)

    Time frame: Baseline

  2. Activated CD8+ T cells

    Time frame: Baseline

    Flow cytometry

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: HIV HEREDITY

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2019
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.