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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV-exposed Uninfected

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads Male or female young adult, 18-30 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 History of being adopted 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 Glucocorticoids (except steroid inhalers or creams) within 3 months Antiretroviral therapy use within 6 months (i.e., prophylaxis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-Exposed Uninfected Dyads<br>Mothers who had HIV during pregnancy and their HIV-negative young adult offspring | |
| HIV-Unexposed Uninfected Dyads<br>Mothers and young adults without HIV | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-exposed Uninfected, In Utero Exposure, Metabolic, Immune