Objectives: Assess the safety and efficacy of tenofovir disoproxil fumarate (TDF) in HIV-1 infected children
Design: Randomized, open label, active-controlled study
Methods: Subjects (2 to < 16 years) on a stavudine (d4T) or zidovudine (ZDV) containing regimen with HIV-1 RNA < 400 copies/ml were randomized to either switch d4T or ZDV to TDF or continue d4T or ZDV. The primary endpoint was the proportion of subjects with HIV-1 RNA < 400 copies/ml at Week 48 with a prespecified non-inferiority margin of 15%. After the 48-week randomized phase, eligible subjects were rolled over to an extension phase.
Results: Ninety-seven children (48 TDF vs 49 d4T or ZDV) were randomized and treated. The percentage of subjects who maintained virologic suppression in the TDF vs d4T or ZDV group at Week 24 were 93.8% vs 89.8% (difference 4.0% [95% CI -6.9% to 14.9%]) and at Week 48 were 83.3% vs 91.8% (difference -8.5% [95% CI -21.5% to 4.5%]) (missing = failure, intent-to-treat analysis). No subjects discontinued study drug due to an adverse event in the 48 weeks of randomized phase. Four subjects discontinued TDF due to proximal renal tubulopathy in the extension phase.
Conclusion: Our study did not demonstrate non-inferiority of TDF vs d4T or ZDV at Week 48. Overall safety and tolerability of TDF in children were consistent with adults. TDF may be considered as an alternative to d4T or ZDV in HIV-infected children.
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