NCT01656564

Clinical Outcomes of People Who Acquired HIV in Early Life

Completed Last updated 9 March 2023

What this trial tests

trial in HIV in 177 participants. Completed in 8 March 2023.

Timeline

27 August 2012

Primary endpoint
8 March 2023

8 March 2023

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	177
Start date	27 August 2012
Primary completion	8 March 2023
Estimated completion	8 March 2023
Sites	1 location across United States

Conditions studied

• HIV — all drugs for HIV →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Increased coronary vessel wall thickness in HIV-infected young adults.
   Abd-Elmoniem KZ, Unsal AB, Eshera S, Matta JR, et al · · 2014 · cited 37× · PMID 25159580 · DOI 10.1093/cid/ciu672
2. Uncovering the NAFLD burden in people living with HIV from high- and middle-income nations: a meta-analysis with a data gap from Subsaharan Africa.
   Manzano-Nunez R, Rivera-Esteban J, Navarro J, Bañares J, et al · · 2023 · cited 24× · PMID 36924219 · DOI 10.1002/jia2.26072
3. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life.
   Unsal AB, Mattingly AS, Jones SE, Purdy JB, et al · · 2017 · cited 20× · PMID 28531309 · DOI 10.1210/jc.2017-00197
4. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults.
   Mattingly AS, Unsal AB, Purdy JB, Gharib AM, et al · · 2017 · cited 11× · PMID 27749650 · DOI 10.1097/inf.0000000000001354
5. Associations Between Central Obesity and Lifelong Antiviral Therapy in Adults Living With HIV Acquired From Early Childhood.
   Sahagun SJ, Yeramosu T, Purdy JB, Reynolds JC, et al · · 2022 · cited 6× · PMID 34693931 · DOI 10.1097/qai.0000000000002841
6. Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease-Risk Persons Living with HIV.
   Abd-Elmoniem KZ, Ishaq H, Purdy J, Matta J, et al · · 2024 · cited 3× · PMID 38573125 · DOI 10.1148/ryct.230102