Heart Function in HIV-Negative Children Exposed to HIV and HAART

NCT01107834 | Completed Results DMC

• 1 other identifier: 10-0121
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

HIV-uninfected children born to HIV+ women have low level heart problems at birth which may predispose them to heart failure, arrythmias and heart attack later in life. The impact of these heart problems on future heart health is unclear as it is unknown if heart problems in these children persist, worsen or resolve in pre-pubescence. The objective of this study is to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and exposed to HIV and HAART in utero and compare them to age and gender matched healthy children born to HIV-negative women. Through this objective we will determine if heart problems in HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or resolves during pre-pubescence.

Conditions

HIV Infections

Keywords

HIV; heart function; HAART; in utero; children

Outcome Measures

Primary Outcomes (2)

• Left Ventricular Mass Index

  left ventricular mass index measured by 2D echocardiography

  Baseline

• Fractional Shortening

  Fractional shortening measured by M-mode cardiography

  Baseline

Secondary Outcomes (4)

• Global Strain Rate

  Baseline

• Systolic Myocardial Velocity During Systole (S')

  Baseline

• Early to Late Diastolic Filling Ratio

  Baseline

• Myocardial Wall Velocity During Early Diastole

  Baseline

Study Arms (2)

Healthy Control

HIV-negative children born to healthy, HIV-negative women

Exposed to HIV/HAART

HIV-negative children exposed to HIV and HAART in utero

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

HIV-negative children will be recruited through their HIV+ mothers who are seen at the AIDS Clinical Trials Unit at Washington University and surrounding St. Louis community clinics. HIV-negative children will be recruit through Washington University and surrounding St. Louis pediatric clinics, and through Washington University Volunteers for Health service.

You may qualify if:

• Age 5-12 years
• Tanner stage I-III
• Born to HIV+ mother
• No HIV infection
• Had taken standard of care prophylactic HAART at birth-1 month of age
• Child currently not taking medications or have medical diagnosis that would affect left ventricular function
• Mother was taking HAART during pregnancy (standard of care)
• Mother was not using illegal drugs during pregnancy
• No intrauterine growth restriction diagnosis during pregnancy
• During pregnancy, mother will not have a diagnosis of type 2 diabetes or gestational diabetes.

You may not qualify if:

• Age 5-12 years
• Tanner stage I-III
• Born to HIV-negative mother
• Mother was not a frequent exerciser during pregnancy (\>2x/week)
• Mother will not have gestational diabetes or a diagnosis of type 2 diabetes during pregnancy of the child being studied
• Child currently not taking medications or have medical diagnosis that would affect left ventricular function

Sponsors & Collaborators

• Washington University School of Medicine: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Cade WT, Waggoner AD, Hubert S, Krauss MJ, Singh GK, Overton ET. Reduced diastolic function and left ventricular mass in HIV-negative preadolescent children exposed to antiretroviral therapy in utero. AIDS. 2012 Oct 23;26(16):2053-8. doi: 10.1097/QAD.0b013e328358d4d7.

  PMID: 22874520 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: William T. Cade
• Organization: Washington University

tcade@wustl.edu

314-286-1432

Study Officials

• William T Cade, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy and Medicine

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 20, 2016
• Results First Posted: July 20, 2016

Record last verified: 2016-06

Locations

US (1)