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.
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-infectedchildren 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.
Authors: Ralf Weigel; Sam Phiri; Fred Chiputula; Joe Gumulira; Martin Brinkhof; Thomas Gsponer; Hannock Tweya; Matthias Egger; Olivia Keiser Journal: Trop Med Int Health Date: 2010-06-15 Impact factor: 2.622
Authors: Tin Tin Sint; Ronnie Lovich; Wendy Hammond; Maria Kim; Sara Melillo; Lydia Lu; Pamela Ching; Jennifer Marcy; Nigel Rollins; Emilia H Koumans; Amie N Heap; Margaret Brewinski-Isaacs Journal: AIDS Date: 2013-11 Impact factor: 4.177
Authors: Andrea L Ciaranello; Yuchiao Chang; Andrea V Margulis; Adam Bernstein; Ingrid V Bassett; Elena Losina; Rochelle P Walensky Journal: Clin Infect Dis Date: 2009-12-15 Impact factor: 9.079
Authors: C Padmapriyadarsini; N Pooranagangadevi; K Chandrasekaran; Sudha Subramanyan; C Thiruvalluvan; P K Bhavani; Soumya Swaminathan Journal: Int J Pediatr Date: 2009-07-02