Pubertal Onset in Children With Perinatal HIV Infection in the Era of Combination Antiretroviral Treatment

AMP, Adolescent Master Protocol; ARV, antiretroviral; CDC, Centers for Disease Control and Prevention; IQR, interquartile range (displayed as 25th–75th percentile); NNRTI, non-nucleoside reverse transcriptase inhibitor; PACTG, Pediatric AIDS Clinical Trials Group; PHACS, Pediatric HIV/AIDS Cohort Study; PI, protease inhibitor.
^aAll HIV-disease related characteristics are based on measures available prior to or at the first pubertal assessment, at age 7 years or older.
^bBMI and height Z-scores are sex- and age-adjusted Z-scores based on CDC 2000 growth standards using the latest BMI and height measured as of the first pubertal assessment. Measures of height and BMI were unavailable for 1 HIV-exposed uninfected child and 35 HIV-infected children.
^cMeasures of past HIV disease severity were unavailable for 19 children for nadir CD4%, and for 536 children for peak viral load. Lack of two viral load measures prevented calculation of copy-years viremia for 989 children.
^dDuration of prior ARV summarized among the subset of youth with any prior use of regimen, and include 1464 with prior combination ARV treatment, 1400 with prior PI use, and 938 with prior NNRTI use; each regimen is considered separately and categories are not mutually exclusive.

Statistical comparisons with reference group (listed first within group) indicated by **denoting P<0.001 and *denoting P<0.05.

ARV, antiretroviral; CDC, Centers for Disease Control and Prevention; CI, confidence interval; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
^aAll estimated shifts in mean age at pubertal onset are based on interval-censored models; and reflect the estimated shift in mean age at pubertal onset for those with vs. without a characteristic, or for each 1-unit change in continuous measures.
^bInterval-censored models for covariate of interest adjusted for race/ethnicity (classified as White non-Hispanic, Black non-Hispanic, Hispanic, or other/unknown race) and birth cohort (classified as pre-1990, 1990–1992, 1993–1996, and 1997 or later).

Authors and Disclosures

Paige L. Williams^a,b, Mark J. Abzug^c, Denise L. Jacobson^a, Jiajia Wang^a, Russell B. Van Dyke^d, Rohan Hazra^e, Kunjal Patel^a,f, Linda A. Dimeglio^g, Elizabeth J. Mcfarland^h, Margarita Silio^d, William Borkowskyⁱ, George R. Seage III^a,f, James M. Oleske^j and Mitchell E. Geffner<sup>k

a</sup>Center for Biostatistics in AIDS Research, ^bDepartment of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, ^cDepartment of Pediatrics (Infectious Diseases), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, ^dTulane University School of Medicine, New Orleans, Louisiana, ^eEunice Kennedy Shriver National Institute of Child Health & Human Development, Bethesda, Maryland, ^fDepartment of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, ^gSection of Pediatric Endocrinology, Indiana University School of Medicine, Indianapolis, Indiana, ^hDepartment of Pediatrics, University of Colorado School of Medicine, Denver, Colorado, ⁱNew York University School of Medicine, New York, ^jDepartment of Pediatrics, New Jersey Medical School, Newark, New Jersey, and ^kSaban Research Institute, Children's Hospital Los Angeles, Los Angeles, California, USA.

Conflicts of interest
Support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases (U01 AI068632) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (contract N01-3-3345 and HHSN267200800001C). This work was also supported by the Statistical and Data Analysis Center at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement #5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group (PACTG) and #1 U01 AI068616 with the IMPAACT Group. The Pediatric HIV/AIDS Cohort Study (PHACS) was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with co-funding from the National Institute of Allergy and Infectious Diseases, the National Institute on Drug Abuse, the National Institute of Mental Health, the National Institute of Deafness and Other Communication Disorders, the National Heart Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Alcohol Abuse and Alcoholism, through cooperative agreements with the Harvard University School of Public Health (U01 HD052102-04) and the Tulane University School of Medicine (U01 HD052104-01). Data management services were provided by Frontier Science and Technology Research Foundation, and regulatory services and logistical support were provided by Westat, Inc. NIH representatives were part of the study team and therefore the sponsor was involved in study design, coordination, data collection, data analysis, data interpretation, and writing of the report. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Correspondence to
Dr Paige Williams, Center for Biostatistics in AIDS Research, Harvard School of Public Health, 655 Huntington Ave, FXB-607, Boston, MA 02115-6017, USA. Tel: +1 617 432 3872; fax: +1 617 432 2832; e-mail: paige@harvard.edu