PEDIATRICS Vol. 104 No. 6 December 1999, p. e73

ELECTRONIC ARTICLE:
Evaluation of the Effects of Oxandrolone on Malnourished HIV-Positive Pediatric Patients

Received Mar 8, 1999; accepted May 25, 1999.

Sarah Fox-Wheeler^*, Linda Heller^*, Cathleen M. Salata^*, Francine Kaufman, M. Louisa Loro^§, Vincente Gilsanz^§, Michael Haight, Gwenn C. Umman^¶, Norman Barton^#, and Joseph A. Church^*

From the ^* Divisions of Clinical Immunology and Allergy,  Endocrinology, ^§ Radiology, and  Gastroenterology, Children's Hospital Los Angeles, Los Angeles, California; ^¶ Vital Research, Los Angeles, California; and ^# Bio-Technology General Corporation, Iselin, New Jersey.

Objective.  To determine the safety and efficacy of anabolic therapy to prevent or reverse wasting and malnutrition in human immunodeficiency virus (HIV)-infected pediatric patients. The anabolic steroid, oxandrolone, was evaluated because of its safe and effective use in other pediatric conditions.

Methods.  Nine HIV-positive children who were malnourished or at risk for malnutrition (4 females, 5 males; 4-14 years of age) took oxandrolone for 3 months (.1 mg/kg/day orally). Quantitative HIV ribonucleic acid polymerase chain reaction and CD4⁺ T-cell levels, complete blood cell count (CBC) and chemistry profile, endocrinologic studies, resting energy expenditure, respiratory quotient, nutritional measures, body composition assessment with quantitative computed tomography, and skinfold body composition measurements were determined before treatment, during treatment (3 months), and for 3 months after treatment. Statistical analyses were completed using the Friedman two-way analysis of variance and Spearman correlation tests.

Results.  No adverse clinical or laboratory events or changes in Tanner staging or virilization occurred. Quantitative HIV ribonucleic acid polymerase chain reaction and CD4⁺ T-cell levels did not change significantly. Insulin-like growth factor 1 increased, suggesting an anabolic effect of treatment. The rate of weight gain increased during treatment and was maintained after treatment. Linear growth continued and was maintained throughout treatment, whereas bone age did not increase significantly. Anthropometric assessments indicated an increase in muscle mass and a decrease in fat while patients were on treatment, and a mild decrease of muscle and increased fat posttreatment. Likewise, computed tomography scan results demonstrated similar changes in muscle mass. Resting energy expenditure and respiratory quotient remained stable throughout treatment and follow-up. No significant changes were seen in the quality of life questionnaire.

Conclusions.  Treatment with oxandrolone for 3 months in HIV-infected children was well-tolerated, safe, and associated with markers of anabolism. The latter effect was maintained partially for 3 months after discontinuation of a 3-month course of therapy. Additional studies are needed to assess the potential benefits and risks of a longer course of therapy or a higher dose of oxandrolone in HIV-infected children.  Key words:  anabolic steroids, oxandrolone, malnutrition, pediatric human immunodeficiency virus wasting syndrome.

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