| Intensification of a triple-nucleoside regimen with tenofovir or efavirenz in HIV-1-infected patients with virological suppression. | |
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MedLine Citation:
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PMID: 17415036 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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/microl. 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 (15%) (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. |
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Authors:
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Roy M Gulick; Christina M Lalama; Heather J Ribaudo; Cecilia M Shikuma; Bruce R Schackman; Jeffrey Schouten; Kathleen E Squires; Susan L Koletar; Christopher D Pilcher; Richard C Reichman; Karin L Klingman; Daniel R Kuritzkes |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: AIDS (London, England) Volume: 21 ISSN: 0269-9370 ISO Abbreviation: AIDS Publication Date: 2007 Apr |
Date Detail:
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Created Date: 2007-04-06 Completed Date: 2007-11-05 Revised Date: 2007-12-03 |
Medline Journal Info:
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Nlm Unique ID: 8710219 Medline TA: AIDS Country: England |
Other Details:
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Languages: eng Pagination: 813-23 Citation Subset: IM; X |
Affiliation:
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Weill Medical College of Cornell University, 525 East 68th Street, New York, NY 10021, USA. rgulick@med.cornell.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adenine
/
adverse effects,
analogs & derivatives*,
therapeutic use Adult Aged Anti-HIV Agents / adverse effects, therapeutic use* Antiretroviral Therapy, Highly Active / adverse effects, methods Benzoxazines / adverse effects, therapeutic use* CD4 Lymphocyte Count Drug Resistance, Viral Female Genotype HIV Infections / drug therapy*, immunology, virology HIV-1* / drug effects, genetics, isolation & purification Humans Male Middle Aged Patient Compliance Phosphonic Acids / adverse effects, therapeutic use* RNA, Viral / blood Reverse Transcriptase Inhibitors / adverse effects, therapeutic use Treatment Outcome Viral Load |
| Grant Support | |
ID/Acronym/Agency:
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AI 01781/AI/NIAID NIH HHS; AI 25859/AI/NIAID NIH HHS; AI 25868/AI/NIAID NIH HHS; AI 25879/AI/NIAID NIH HHS; AI 25897/AI/NIAID NIH HHS; AI 25903/AI/NIAID NIH HHS; AI 25915/AI/NIAID NIH HHS; AI 25924/AI/NIAID NIH HHS; AI 27658-61/AI/NIAID NIH HHS; AI 27664/AI/NIAID NIH HHS; AI 27668/AI/NIAID NIH HHS; AI 27670/AI/NIAID NIH HHS; AI 27673/AI/NIAID NIH HHS; AI 27675/AI/NIAID NIH HHS; AI 27767/AI/NIAID NIH HHS; AI 28697/AI/NIAID NIH HHS; AI 32775/AI/NIAID NIH HHS; AI 32782/AI/NIAID NIH HHS; AI 34832/AI/NIAID NIH HHS; AI 38855/AI/NIAID NIH HHS; AI 38858/AI/NIAID NIH HHS; AI 39156/AI/NIAID NIH HHS; AI 42848/AI/NIAID NIH HHS; AI 42851/AI/NIAID NIH HHS; AI 46339/AI/NIAID NIH HHS; AI 46381/AI/NIAID NIH HHS; AI 46386/AI/NIAID NIH HHS; AI 50410/AI/NIAID NIH HHS; AI 51966/AI/NIAID NIH HHS; RR 00044/RR/NCRR NIH HHS; RR 00046/RR/NCRR NIH HHS; RR 00047/RR/NCRR NIH HHS; RR 00052/RR/NCRR NIH HHS; RR 00865/RR/NCRR NIH HHS; RR 02635/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anti-HIV Agents; 0/Benzoxazines; 0/Phosphonic Acids; 0/RNA, Viral; 0/Reverse Transcriptase Inhibitors; 107021-12-5/tenofovir; 154635-17-3/efavirenz; 73-24-5/Adenine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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