Document Detail


Intensification of a triple-nucleoside regimen with tenofovir or efavirenz in HIV-1-infected patients with virological suppression.
MedLine Citation:
PMID:  17415036     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
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:
Title:  AIDS (London, England)     Volume:  21     ISSN:  0269-9370     ISO Abbreviation:  AIDS     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-06     Completed Date:  2007-11-05     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  813-23     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
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
Organophosphonates / adverse effects,  therapeutic use*
Patient Compliance
RNA, Viral / blood
Reverse Transcriptase Inhibitors / adverse effects,  therapeutic use
Treatment Outcome
Viral Load
Grant Support
ID/Acronym/Agency:
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:
0/Anti-HIV Agents; 0/Benzoxazines; 0/Organophosphonates; 0/RNA, Viral; 0/Reverse Transcriptase Inhibitors; 107021-12-5/tenofovir; JAC85A2161/Adenine; JE6H2O27P8/efavirenz

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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