A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV.
BACKGROUND
HIV adversely affects growth in children. Pediatric AIDS Clinical Trial Group (PACTG) protocols often use weight velocity [changes in weight z-score for age (WAZ)] as a part of the composite endpoint for phase II and III clinical trials. However, WAZ and height velocity (HAZ) have not been critically compared for their utility as part of the composite endpoint.


METHODS
HAZ and WAZ were compared to predict laboratory and clinical progression of HIV in a retrospective cohort study of HIV-infected children with data from PACTG Protocol 300.


RESULTS
In both bivariable and multivariable analyses, changes in HAZ were more closely linked to subsequent progression than WAZ. Children with improved HAZ were somewhat less likely to exhibit virological failure [odds ratio (OR), 0.76; 95% confidence interval (CI) 0.51-1.14], than children with improved WAZ (OR, 1.45; 95% CI, 0.99,2.11). Children who had improved HAZ were less likely to exhibit immunological failure (OR, 0.7; 95% CI, 0.49-1.00), than children with improved WAZ (OR, 1.13; 95% CI, 0.82-1.57). Children who had improved HAZ were less likely to have other forms of clinical progression of HIV (OR, 0.55; 95% CI, 0.31-0.99), than children who had improved WAZ (OR, 1.0; 95% CI, 1.58-1.94).


CONCLUSIONS
Increases in HAZ were associated with reduced risk of subsequent clinical progression and subsequent immune reconstitution and weakly associated with declines in HIV RNA. Changes in WAZ were not associated with laboratory outcomes relevant to pediatric HIV infection. Height velocity should be considered as a component of a composite clinical endpoint in future PACTG trials.
Benjamin
Daniel K
DK
Duke Clinical Research Institute and the Department of Pediatrics, Duke University, Durham, North Carolina, USA.
Miller
Wiliam C
WC
Benjamin
Daniel K
DK
Ryder
Robert W
RW
Weber
David J
DJ
Walter
Emmanuel
E
McKinney
Ross E
RE
D000293:Adolescent; D000886:Anthropometry; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001827:Body Height / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D005260:Female; D006128:Growth / Q000187:drug effects*; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology*; D006801:Humans; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load; D015430:Weight Gain / Q000187:drug effects
D019380:Anti-HIV Agents