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

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 Overview

• Status: Recruiting
• Conditions: HIV-exposed Uninfected

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Lindsay T Fourman, MD; Phone Number: 617-643-4590; Email: LFourman@partners.org
• Study Contact Backup: Name: Isabel Zheng; Phone Number: 67-643-4420; Email: IZheng@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Lindsay T Fourman, MD; Phone Number: 617-643-4590; Email: LFourman@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)		Baseline
Activated CD8+ T cells	Flow cytometry	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal fat mass	Dual-energy x-ray absorptiometry	Baseline
Glucose tolerance	Oral glucose tolerance test	Baseline
Lipids	Standard lipid panel (including HDL, triglycerides)	Baseline
Blood pressure	Systolic and diastolic	Baseline
Hepatic fat content	Transient elastography	Baseline
Hepatic fibrosis	Transient elastography	Baseline
Immune cell subsets	Flow cytometry	Baseline
Inflammatory markers	ELISA	Baseline
Frequency of Asthma		Baseline, Ever
DNA methylation patterns	Epigenome-wide analysis	Baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Lindsay T Fourman, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Immune; Metabolic; In Utero Exposure; HIV-exposed Uninfected
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 2019P000629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No