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

HIV-exposed Uninfected Clinical Trial

— HIV HEREDITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132830
• Other study ID #: 2019P000629
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: Lindsay T Fourman, MD
• Phone: 617-643-4590
• Email: LFourman[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV-exposed Uninfected
• Metabolic Diseases

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)		Baseline
Primary	Activated CD8+ T cells	Flow cytometry	Baseline
Secondary	Abdominal fat mass	Dual-energy x-ray absorptiometry	Baseline
Secondary	Glucose tolerance	Oral glucose tolerance test	Baseline
Secondary	Lipids	Standard lipid panel (including HDL, triglycerides)	Baseline
Secondary	Blood pressure	Systolic and diastolic	Baseline
Secondary	Hepatic fat content	Transient elastography	Baseline
Secondary	Hepatic fibrosis	Transient elastography	Baseline
Secondary	Immune cell subsets	Flow cytometry	Baseline
Secondary	Inflammatory markers	ELISA	Baseline
Secondary	Frequency of Asthma		Baseline, Ever
Secondary	DNA methylation patterns	Epigenome-wide analysis	Baseline