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Completed

NCT Number: NCT01656564

Clinical Outcomes of People Who Acquired HIV in Early 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Health Status

    Time frame: End of Study

    vital status and health outcomes will be determined annually throughout the study

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Clinical Outcomes in Persons With HIV Acquired Early in Life

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2012
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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