Vertex Pharmaceuticals and Glaxo Wellcome have initiated a Phase IIItrial to evaluate the safety and efficacy of the protease inhibitor 141W94 (VX-478) in combination with nucleoside reverse transcriptase inhibitors in HIV-infected children.
The study will enroll around 210 patients between the ages of six months and 18 years who have not previously been treated with protease inhibitors. Patients will be assessed at weeks 16 and 48 respectively for antiviral efficacy and durability of response. At both these time intervals, changes in CD4 cell counts will also be evaluated.
GW and Vertex are currently conducting another Phase III trial of the drug in combination with zidovudine and lamivudine in adults.
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