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Background:  Elevation of cholesterol or triglycerides is a well-documented side effect of HAART, however, minimal effect on cholesterol/triglycerides are needed as long-term regimens are considered. Pediatric AIDS Clinical Trials Group (PACTG) 1020A is a prospective open-label, non-randomized phase I/II study of atazanavir (ATV), in combination with 2 nucleoside reverse transcriptase inhibitors (NRTI), in HIV-infected children. It is designed to determine the safety, pharmacokinetics, and optimal dosage of ATV powder and capsules.  

Methods:  ART-naïve and -experienced children were studied who exhibited pheno-susceptibility (ATV IC₅₀ fold change < 10), had HIV RNA > 5000 copies/mL, and were aged 91 days to 21 years. Starting dose of ATV was 310 mg/m² daily (adjusted upward to a maximum of 800 mg if pre-set pharmacokinetic criteria were not met). At weeks 24 and 48, percentage of change from baseline was assessed for triglycerides  and cholesterol. Patients with missing baseline measurements were excluded from the analysis, as were early discontinuations (≤ 8 weeks). Possible effects of previous ART exposure were tested, i.e., median percentage changes in triglycerides and cholesterol were compared for naïve vs experienced patients (Kruskal-Wallis Test). Spearman correlation was used to evaluate whether the patient’s last recorded percentage of changes were related to time on ATV.

Results:  To date, 63 patients have been enrolled and received ATV. Previous ART experience had no significant effects on both triglycerides/cholesterol (at week 24, triglycerides p = 0.17, cholesterol p = 0.46; at week 48, triglycerides p = 0.65, cholesterol p = 0.29). Thus, data were pooled. At baseline, median cholesterol was 139 (n = 54, range 71 to 241) and median triglycerides were 115 (n = 55, range 31 to 401). There was no significant change from baseline through week 48. Spearman correlation showed that there was no significant association between triglycerides and cholesterol changes and the duration of taking ATV (triglycerides, n = 55, r = 0.20, p = 0.14; cholesterol, n = 54, r = 0.08, p = 0.54).

Conclusions:  At 24 and 48 weeks, treatment with ATV in combination with 2 NRTI had no significant effect on serum cholesterol or triglycerides. This offers a potential advantage of ATV-containing regimens. We await further safety and dosage information from PACTG 1020A.

Keywords: Atazanavir; Pediatrics; cholesterol/triglycerides