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

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ClinicalTrials.gov Identifier: NCT04132830
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Lindsay Fourman, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date October 7, 2019
First Posted Date October 21, 2019
Last Update Posted Date August 14, 2023
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2019)
  • Body mass index (BMI) [ Time Frame: Baseline ]
  • Activated CD8+ T cells [ Time Frame: Baseline ]
    Flow cytometry
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 18, 2019)
  • Abdominal fat mass [ Time Frame: Baseline ]
    Dual-energy x-ray absorptiometry
  • Glucose tolerance [ Time Frame: Baseline ]
    Oral glucose tolerance test
  • Lipids [ Time Frame: Baseline ]
    Standard lipid panel (including HDL, triglycerides)
  • Blood pressure [ Time Frame: Baseline ]
    Systolic and diastolic
  • Hepatic fat content [ Time Frame: Baseline ]
    Transient elastography
  • Hepatic fibrosis [ Time Frame: Baseline ]
    Transient elastography
  • Immune cell subsets [ Time Frame: Baseline ]
    Flow cytometry
  • Inflammatory markers [ Time Frame: Baseline ]
    ELISA
  • Frequency of Asthma [ Time Frame: Baseline, Ever ]
  • DNA methylation patterns [ Time Frame: Baseline ]
    Epigenome-wide analysis
Original Secondary Outcome Measures
 (submitted: October 16, 2019)
  • Abdominal fat mass [ Time Frame: Baseline ]
    Dual-energy x-ray absorptiometry
  • Glucose tolerance [ Time Frame: Baseline ]
    Oral glucose tolerance test
  • Lipids [ Time Frame: Baseline ]
    Standard lipid panel
  • Blood pressure [ Time Frame: Baseline ]
    Systolic and diastolic
  • Hepatic fat content [ Time Frame: Baseline ]
    Transient elastography
  • Hepatic fibrosis [ Time Frame: Baseline ]
    Transient elastography
  • Immune cell subsets [ Time Frame: Baseline ]
    Flow cytometry
  • Inflammatory markers [ Time Frame: Baseline ]
    ELISA
  • Frequency of Asthma [ Time Frame: Baseline, Ever ]
  • DNA methylation patterns [ Time Frame: Baseline ]
    Epigenome-wide analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population We are recruiting mothers who had HIV during pregnancy and their HIV-negative young adult offspring (18-30 years old). We are also recruiting mothers and their young adult offspring without HIV to serve as controls.
Condition HIV-exposed Uninfected
Intervention Not Provided
Study Groups/Cohorts
  • HIV-Exposed Uninfected Dyads
    Mothers who had HIV during pregnancy and their HIV-negative young adult offspring
  • HIV-Unexposed Uninfected Dyads
    Mothers and young adults without HIV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 16, 2019)		 300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA:

HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads

  1. Male or female young adult, 18-30 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. History of being adopted
  2. Pregnancy within 6 months or active nursing
  3. Change in blood glucose or blood pressure medication within 3 months
  4. Change in estrogen or testosterone therapy within 3 months
  5. Glucocorticoids (except steroid inhalers or creams) within 3 months
  6. Antiretroviral therapy use within 6 months (i.e., prophylaxis)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lindsay T Fourman, MD 617-643-4590 LFourman@partners.org
Contact: Isabel Zheng 67-643-4420 IZheng@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04132830
Other Study ID Numbers 2019P000629
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Lindsay Fourman, MD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Lindsay T Fourman, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2023