Clinical Outcomes of People Who Acquired HIV in Early Life

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Active, not recruiting

CT.gov ID

NCT01656564

Collaborator

(none)

177

Enrollment

Location

Study Details

Study Description

Brief 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....

Condition or Disease	Intervention/Treatment	Phase
HIV

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 Design

Study Type:

Observational

Actual Enrollment :

177 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Outcomes in Persons With HIV Acquired Early in Life

Actual Study Start Date :

Aug 27, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Health Status [End of Study]
vital status and health outcomes will be determined annually throughout the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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