N/A
N=60
Heart Function in HIV-Negative Children Exposed to HIV and HAART
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT01107834 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Left Ventricular Mass Index — 67; 60 g/m2 — p=0.27
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Mass Index |
67; 60 | 0.27 |
| PRIMARY Fractional Shortening |
36; 37 | 0.46 |
| SECONDARY Global Strain Rate |
-22.3; -21.1 | 0.13 |
| SECONDARY Systolic Myocardial Velocity During Systole (S') |
9.3; 9.1 | 0.59 |
| SECONDARY Early to Late Diastolic Filling Ratio |
2.1; 1.8 | 0.09 |
| SECONDARY Myocardial Wall Velocity During Early Diastole |
16.3; 15.0 | 0.03 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01107834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.