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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
HIV-Exposed Uninfected Dyads Mothers who had HIV during pregnancy and their HIV-negative young adult offspring
  • Other: In Utero HIV Exposure
    Born to mother who had HIV infection during pregnancy.
HIV-Unexposed Uninfected Dyads Mothers and young adults without HIV
  • Other: No In Utero HIV Exposure
    Born to mother who did not have HIV infection during pregnancy.

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.