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

NCT ID: NCT04132830

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 174 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2024-07-26

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.

Conditions

HIV-exposed Uninfected

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HIV-Exposed Uninfected Dyads

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

In Utero HIV Exposure

Intervention Type: OTHER

Born to mother who had HIV infection during pregnancy.

HIV-Unexposed Uninfected Dyads

Mothers and young adults without HIV

No In Utero HIV Exposure

Intervention Type: OTHER

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

Interventions

In Utero HIV Exposure

Born to mother who had HIV infection during pregnancy.

Intervention Type: OTHER

No In Utero HIV Exposure

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Fourman, MD

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay T Fourman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P000629

Identifier Type: -

Identifier Source: org_study_id