Trial Outcomes & Findings for Heart Function in HIV-Negative Children Exposed to HIV and HAART (NCT NCT01107834)

NCT ID: NCT01107834

Last Updated: 2016-07-20

Results Overview

left ventricular mass index measured by 2D echocardiography

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2016-07-20

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero	Total n=60 Participants Total of all reporting groups
Age, Continuous	8 years STANDARD_DEVIATION 2 • n=5 Participants	8 years STANDARD_DEVIATION 3 • n=7 Participants	8 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

left ventricular mass index measured by 2D echocardiography

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Left Ventricular Mass Index	67 g/m2 Standard Deviation 12	60 g/m2 Standard Deviation 9

PRIMARY outcome

Timeframe: Baseline

Fractional shortening measured by M-mode cardiography

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Fractional Shortening	36 percentage of full contraction Standard Deviation 5	37 percentage of full contraction Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline

Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Global Strain Rate	-22.3 percentage of full deformation Standard Deviation 3.2	-21.1 percentage of full deformation Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline

Systolic myocardial velocity during systole measured by tissue Doppler echocardiography

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Systolic Myocardial Velocity During Systole (S')	9.3 cm/s Standard Deviation 1.1	9.1 cm/s Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline

Early to late diastolic filling ratio measured by tissue Doppler echocardiography

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Early to Late Diastolic Filling Ratio	2.1 ratio, unitless Standard Deviation 0.5	1.8 ratio, unitless Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline

Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging

Outcome measures

Measure	Healthy Control n=30 Participants HIV-negative children born to healthy, HIV-negative women	Exposed to HIV/HAART n=30 Participants HIV-negative children exposed to HIV and HAART in utero
Myocardial Wall Velocity During Early Diastole	16.3 cm/s Standard Error 2.5	15.0 cm/s Standard Error 2.2

Adverse Events

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exposed to HIV/HAART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William T. Cade

Washington University

Phone: 314-286-1432

Email: tcade@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place