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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03228966
Date of registration:	21/07/2017
Prospective Registration:	Yes
Primary sponsor:	Duke University
Public title:	Ped HIV - Echo Study: Kenya
Scientific title:	Evaluating Indicators of Cardiac Function in Children Living With HIV in Western Kenya
Date of first enrolment:	September 12, 2017
Target sample size:	643
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03228966
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Kenya

Contacts

Name:	Andrew W McCrary, MD
Address:
Telephone:
Email:
Affiliation:	Duke University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Attending HIV care clinic for regular follow up visit

- < 14 years old

- Diagnosed HIV prior to age 10

- caregiver gives consent

Exclusion Criteria:

- unable to cooperate with echocardiogram

Age minimum: 1 Month
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV/AIDS

Cardiomyopathies

Intervention(s)

Diagnostic Test: Echocardiogram

Primary Outcome(s)

Cardiac function inversely associated with HIV viral load [Time Frame: Day of clinic visit laboratory results]

Cardiac function inversely associated with inflammatory marker levels [Time Frame: Day of clinic visit laboratory results]

Cardiac function inversely associated with bio-marker levels [Time Frame: Day of clinic visit]

Secondary Outcome(s)

Secondary ID(s)

Pro00083416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fogarty International Center of the National Institute of Health

Duke Center for AIDS Research

International AIDS Society

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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