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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132830
Acronym
HIV HEREDITY
Enrollment
174
Registered
2019-10-21
Start date
2019-10-01
Completion date
2024-07-26
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-exposed Uninfected

Keywords

HIV-exposed Uninfected, In Utero Exposure, Metabolic, Immune

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.

Interventions

OTHERIn Utero HIV Exposure

Born to mother who had HIV infection during pregnancy.

OTHERNo In Utero HIV Exposure

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads 1. Male or female young adult, 18-35 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. Pregnancy within 6 months or active nursing 2. Change in blood glucose or blood pressure medication within 3 months 3. Change in estrogen or testosterone therapy within 3 months 4. Chronic glucocorticoids (except steroid inhalers or creams) within 3 months 5. Antiretroviral therapy use within 6 months (i.e., prophylaxis) 6. Significant chronic illness judged by the investigator to represent a contraindication to participation

Design outcomes

Primary

MeasureTime frameDescription
Body mass index (BMI)Baseline
Activated CD8+ T cellsBaselineFlow cytometry

Secondary

MeasureTime frameDescription
LipidsBaselineStandard lipid panel (including HDL, triglycerides)
Blood pressureBaselineSystolic and diastolic
Hepatic fat contentBaselineTransient elastography
Hepatic fibrosisBaselineTransient elastography
Abdominal fat massBaselineDual-energy x-ray absorptiometry
Inflammatory markersBaselineELISA
Frequency of AsthmaBaseline, Ever
DNA methylation patternsBaselineEpigenome-wide analysis
Immune cell subsetsBaselineFlow cytometry
Glucose toleranceBaselineOral glucose tolerance test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026