Clinical trial NCT04132830: HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
Official title: HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-exposed Uninfected
Keywords: HIV-exposed Uninfected
In Utero Exposure
Metabolic
Immune
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We are recruiting mothers who had HIV during pregnancy and their HIV-negative young adult offspring (18-35 years old). We are also recruiting mothers and their young adult offspring without HIV to serve as controls.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Activated CD8+ T cells
timeFrame: Baseline
Secondary outcomes:
measure: Abdominal fat mass
timeFrame: Baseline
measure: Glucose tolerance
timeFrame: Baseline
measure: Lipids
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Hepatic fat content
timeFrame: Baseline
measure: Hepatic fibrosis
timeFrame: Baseline
measure: Immune cell subsets
timeFrame: Baseline
measure: Inflammatory markers
timeFrame: Baseline
measure: Frequency of Asthma
timeFrame: Baseline, Ever
measure: DNA methylation patterns
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lindsay T Fourman, MD
role: PRINCIPAL_INVESTIGATOR
References: