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

Mass General Brigham

Status: Completed

Conditions: HIV-exposed Uninfected

Treatments: Other: No In Utero HIV Exposure; Other: In Utero HIV Exposure

Study type: Observational

Funder types: Other

Identifiers

NCT04132830

2019P000629

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

174 participants in 2 patient groups

HIV-Exposed Uninfected Dyads

Description:

Mothers who had HIV during pregnancy and their HIV-negative young adult offspring

Treatment:

Other: In Utero HIV Exposure

HIV-Unexposed Uninfected Dyads

Description:

Mothers and young adults without HIV

Treatment:

Other: No In Utero HIV Exposure