NCT04132830Completed
HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
Source: ClinicalTrials.gov · Last updated 23 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 174 (actual)
- First submitted
- 7 Oct 2019
- Start date
- 1 Oct 2019
- Primary completion date
- 26 Jul 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT04132830
What you commit to
- Study type: Observational
- Participants enrolled: 174
- From 1 Oct 2019 to the primary completion date, 26 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in estrogen or testosterone therapy within 3 months
- Chronic glucocorticoids (except steroid inhalers or creams) within 3 months
- Antiretroviral therapy use within 6 months (i.e., prophylaxis)
Other illness
- Significant chronic illness judged by the investigator to represent a contraindication to participation
Lab values
- Change in blood glucose or blood pressure medication within 3 months
Other
- All Young Adults
- Pregnancy within 6 months or active nursing
Who the study is looking for
- HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads
- Male or female young adult, 18-35 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.