Clinical Outcomes of People Who Acquired HIV in Early Life

HIV Clinical Trial

Official title:

Clinical Outcomes in Persons With HIV Acquired Early in Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656564
• Other study ID #: 120157
• Secondary ID: 12-I-0157
• Status: Completed
• Start date: August 27, 2012
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aepfelbacher JA, Chaudhury CS, Mee T, Purdy JB, Hawkins K, Curl KA, Dee N, Hadigan C. Reproductive and sexual health knowledge, experiences, and milestones in young adults with life-long HIV. AIDS Care. 2020 Mar;32(3):354-361. doi: 10.1080/09540121.2019.1679711. Epub 2019 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Status	vital status and health outcomes will be determined annually throughout the study	End of Study

External Links

•   NIH Clinical Center Detailed Web Page