Clinical Outcomes of People Who Acquired HIV in Early Life

March 8, 2023 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Clinical Outcomes in Persons With HIV Acquired Early in Life

Background:

- Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Researchers are interested in studying how HIV infection and the medicines used to treat it affect people who were infected early in life. They want to find out if there are any problems with how HIV-infected children grow and develop as adults, especially if they have developed heart problems. As part of this study, people with HIV will be compared with healthy volunteers.

Objectives:

- To study the effect of HIV infection and treatment on people who acquired HIV infection in early life.

Eligibility:

  • Individuals at least 18 years of age who acquired HIV infection in early life.
  • Healthy volunteers at least 18 years of age without HIV will serve as controls

Design:

  • Participants will be screened with a physical exam and medical history. They will have regular study visits about once a year for up to 10 years to collect health information.
  • Blood and urine samples will be collected to look at kidney and liver function.
  • X-ray scans will be used to look at bone density and the amount of fat and muscle in the body.
  • Treatment will not be provided as part of this study.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

  • Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
  • Long-term survivors of pediatric HIV infection offer a tremendous opportunity to understand the effects of HIV and ART health outcomes.
  • A thorough understanding of the impact of HIV and ART on these long-term processes is extremely relevant as ART programs for HIV-infected children expand globally.

Objective:

- To explore the clinical outcomes and the impact of HIV infection and ART on a cohort with HIV infection acquired in early life

Eligibility:

  • Individuals at least 18 years of age who acquired HIV infection in early life
  • Healthy volunteers without HIV (greater than or equal to 18 years of age) will serve as controls

Design:

- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted.

Study Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV infected young adults; Healthy volunteers

Description

  • INCLUSION CRITERIA:

  • HIV positive participants

    • Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life
    • Age greater than or equal to 18 years

  • HIV negative controls

    • HIV negative, documented by a negative ELISA
    • Age greater than or equal to 18 years
    • Free of any major underlying medical disorder
    • Not currently pregnant

For Reproductive Health Sub-Study:

  • HIV positive participants

    • Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life
    • Age greater than or equal to 18 years
    • Capable of providing independent informed consent

  • HIV negative controls

    • HIV negative, verified by a negative ELISA
    • Age greater than or equal to 18 years

For Healthy Volunteer, Questionnaire Group only

  • Age >=18 years
  • No known history of HIV

EXCLUSION CRITERIA:

Clinically significant condition or systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy Controls
Individuals with no known history of HIV
Healthy Controls - Questionnaire Group
Individuals with no known history of HIV
HIV
Individuals who acquired HIV in early life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Status
Time Frame: End of Study
vital status and health outcomes will be determined annually throughout the study
End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Colleen M Hadigan, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2012

Primary Completion (Actual)

March 8, 2023

Study Completion (Actual)

March 8, 2023

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 120157
  • 12-I-0157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

.This is not an interventional study. This is a natural history study. Results are provided in aggregate in the form of published journal articles.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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