The first large study in pediatric patients to compare an HIV proteaseinhibitor with nucleoside analog therapy has demonstrated that treatment with Abbott Laboratories' Norvir (ritonavir) resulted in higher rates of undetectable HIV RNA at 12 weeks.
298 HIV-positive, antiretroviral-experienced children aged two-17 were enrolled in the Phase II trial, conducted by the Pediatric AIDS Clinical Trials Group, and were administered either ritonavir plus Bristol-Myers Squibb's nucleoside analog Zerit (stavudine), ritonavir plus Glaxo Wellcome's nucleoside analogs Retrovir/AZT (zidovudine) and Epivir/3TC (lamivudine), or zidovudine and lamivudine alone.
After 12 weeks, 61% of the ritonavir/stavudine group had undetectable levels of the virus (less than 400 copies/mL), while 57% of the ritonavir/zidovudine/lamivudine group had undetectable plasma HIV RNA, compared with only 14% in the zidovudine/lamivudine group. Furthermore, the number of CD4 cells increased more in the two groups receiving ritonavir. The researchers say that the durability of the RNA response is yet to be determined.
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