期刊
AIDS
卷 21, 期 7, 页码 813-823出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/QAD.0b013e32805e8753
关键词
abacavir; antiretroviral therapy; efavirenz; lamivudine; non-nucleoside reverse transcriptase inhibitors; nucleoside reverse transcriptase inhibitors; quadruple nucleosides; tenofovir; zidovudine
资金
- NCRR NIH HHS [RR 02635, RR 00865, RR 00052, RR 00047, RR 00046, RR 00044] Funding Source: Medline
- NIAID NIH HHS [AI 25915, AI 25924, AI 27658-61, AI 27664, AI 27668, AI 27670, AI 27673, AI 27675, AI 27767, AI 28697, AI 32775, AI 32782, AI 34832, AI 38855, AI 38858, AI 39156, AI 42848, AI 42851, AI 46339, AI 46381, AI 46386, AI 50410, AI 51966, AI 25903, AI 25897, AI 25879, AI 25868, AI 25859, AI 01781] Funding Source: Medline
Objective: To compare a quadruple-nucleoside with an efavirenz-containing regimen for treatment of HIV-1 infection. Design: A randomized, open-label study of the AIDS Clinical Trials Group (ACTG). Methods: Subjects receiving zidovudine/lamivudine/abacavir on ACTG 5095 with HIV-1 RNA less than 200 copies/ml were randomly assigned to intensify either with tenofovir or efavirenz. Subjects were followed for time to treatment failure, defined as either virological failure or treatment discontinuation. Analyses were intent-to-treat. Results: One hundred and seventy subjects (21% women; 56% non-white) entered the study. At baseline, 95 and 73% had HIV-1-RNA levels less than 200 and 50 copies/ml, respectively; the median CD4 cell count was 453 cells/mu l. Over a median 79 weeks follow-up, 165 (97%) completed the study, three (2%) discontinued, and two (1%) died. Treatment failure occurred in 31 subjects: 18 (21%) (quadruple nucleosides) and 13 (151%) (efavirenz-containing regimen); however the failure-time curves crossed and demonstrated a non-constant treatment effect over time, characterized by more early treatment failures on the efavirenz-containing regimen and more late treatment failures on the four-nucleoside regimen. HIV-1 RNA remained suppressed in more than 88%, of subjects to less than 200 copies/ml and in more than 78% to less than 50 copies/ml at weeks 24, 48, and 72, without differences by treatment arm. There were no significant differences between the regimens in CD4 cell increases, time to new grade 3/4 adverse events, or adherence. Conclusion: The safety, tolerability, and efficacy of the four-nucleoside regimen were not significantly different from the efavirenz-containing regimen. These pilot data support further investigation of the quadruple-nucleoside regimen. (c) 2007 Lippincott Williams & Wilkins.
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