In:
Antiviral Therapy, SAGE Publications, Vol. 8, No. 6 ( 2003-08), p. 595-602
Abstract:
A triple-class HAART regimen may be associated with a better virological effect than conventional regimens, but may also lead to toxicity and more profound resistance. Methods Randomized, controlled, open-label trial of 233 protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive HIV-infected patients allocated to a regimen of nelfinavir and nevirapine (1250/200 mg twice daily; n=118) or ritonavir and saquinavir (400/400 mg twice daily; n=115), both in combination with two nucleoside reverse transcriptase inhibitors. The primary end-point was HIV RNA ≤20 copies/ml after 48 weeks (missing value=failure). Patients remained under follow-up also in case of switch from the randomized therapy. Results At baseline, the median CD4 cell counts were 126 (range: 0–942) (nelfinavir/nevirapine) and 150 (0–642) (ritonavir/saquinavir) cells/mm 3 , and HIV RNA measurements 5.0 copies/ml (1.3–6.4) in both groups. A total of 102 (86%) and 101 (88%) were antiretroviral-naive. Within 48 weeks, 35 and 44% discontinued randomized therapy; P=0.13. Of these, 80 and 73% switched therapy due to adverse events; P=0.99. At week 48, 69 and 56%, respectively, had a HIV RNA ≤20 copies/ml; P=0.037. Conclusion A regimen of nelfinavir/nevirapine had a favourable virological effect and tolerability over a 48-week period compared with ritonavir/saquinavir, when administered in combination with two nucleoside reverse transcriptase inhibitors. However, more extensive follow-up is required to determine the long-term consequences of triple class HAART regimens, including the development of broad drug resistance.
Type of Medium:
Online Resource
ISSN:
1359-6535
,
2040-2058
DOI:
10.1177/135965350300800611
Language:
English
Publisher:
SAGE Publications
Publication Date:
2003
detail.hit.zdb_id:
2118396-X
SSG:
15,3
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