Important note: Information in this article was accurate in February 2000. The state of the art may have changed since the publication date.AIDSWEEKLY Plus; Monday, February 14, 2000
Prepared by AIDS Weekly editors from staff and other reports
"Although protease inhibitors are used routinely in adults with human immunodeficiency virus (HIV) infection, the role of these drugs in the treatment of clinically stable HIV infected children is not clear," wrote Sharon A. Nachman and colleagues for the Pediatric AIDS Clinical Trials Group 338 Study Team. The group incorporated researchers from several institutions in New York and Massachusetts, USA.
Nachman et al. published the results of their clinical trial in the Journal of the American Medical Association ("Nucleoside Analogs Plus Ritonavir in Stable Antiretroviral Therapy-Experienced HIV Infected Children: A Randomized Controlled Trial," JAMA 2000 Jan 26;283(4):492-8.
The researchers evaluated the safety, tolerance, and virologic response produced by a change in antiretroviral therapy in HIV infected children. The children included in the trial must have been clinically and immunologically stable while receiving previous therapy.
The Pediatrics AIDS Clinical Trials Group 338 conducted a multicenter, Phase II, randomized, open-label controlled trial. The patient entry period for the trial was from February 6 to April 30, 1997. Patients were followed up for 48 weeks, noted the researchers.
The pediatric HIV research clinics were in the United States and Puerto Rico. There were 297 antiretroviral-experienced, protease inhibitor-naive, clinically stable HIV infected children enrolled in the trial. Age of the children ranged from 2 to 17 years.
According to the authors, the children were randomized to receive either zidovudine, 160 mg/m2 3 times per day, plus lamivudine, 4 mg/kg 2 times per day (n=100); or the same regimen plus ritonavir, 350 mg/m2 2 times per day (n=100); or ritonavir, 350 mg/m2 2 times per day, and stavudine, 4 mg/kg 2 times per day (n=97). Plasma HIV-1 RNA levels were compared among the 3 treatment groups at study weeks 12 and 48.
The researchers found that at study week 12, 12% of the patients in the zidovudine-lamivudine group had undetectable plasma HIV RNA levels (<400 copies/mL) compared with 52% and 54% of patients in the 2- and 3-drug ritonavir-containing groups, respectively (P<.001). Seventy percent of the children continued receiving their ritonavir-containing regimen through study week 48.
At study week 48, 42% of the children receiving ritonavir plus 2 nucleosides compared with 27% of those receiving ritonavir and a single nucleoside had undetectable HIV RNA levels (P=.04). However, noted the researchers, similar proportions in each group continuing initial therapy had HIV RNA levels of less than 10,000 copies/mL (58% vs 48%, respectively; P=.19).
"In our study, change in antiretroviral therapy to a ritonavir-containing regimen was associated with superior virologic response at study week 12 compared with change to a dual nucleoside analog regimen," concluded Nachman et al. "More children receiving ritonavir in combination with 2 compared with 1 nucleoside analog had undetectable HIV RNA levels at study week 48."
The corresponding author for this study is Sharon A. Nachman, State University of New York at Stony Brook, HSC T11, 080, Stony Brook, New York 11794-8111; e-mail: <snachman@mail.som.sunsb.edu>.
This research was supported in part by the Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases, the Pediatric/Perinatal HIV Clinical Trials Network of the National Institute of Child Health and Human Development, Abbott Laboratories, Glaxo-Wellcome, and Bristol-Myers Squibb; and by a grant from the US National Institutes of Health, #AI-41110.
The key findings are:
This article was prepared by AIDS Weekly editors from staff and other reports.
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