Document Detail

Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection.
MedLine Citation:
PMID:  20151839     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The MERIT (Maraviroc versus Efavirenz in Treatment-Naive Patients) study compared maraviroc and efavirenz, both with zidovudine-lamivudine, in antiretroviral-naive patients with R5 human immunodeficiency virus type 1 (HIV-1) infection.
METHODS: Patients screened for R5 HIV-1 were randomized to receive efavirenz (600 mg once daily) or maraviroc (300 mg once or twice daily) with zidovudine-lamivudine. Coprimary end points were proportions of patients with a viral load <400 and <50 copies/mL at week 48; the noninferiority of maraviroc was assessed.
RESULTS: The once-daily maraviroc arm was discontinued for not meeting prespecified noninferiority criteria. In the primary 48-week analysis (n = 721), maraviroc was noninferior for <400 copies/mL (70.6% for maraviroc vs 73.1% for efavirenz) but not for <50 copies/mL (65.3% vs 69.3%) at a threshold of -10%. More maraviroc patients discontinued for lack of efficacy (11.9% vs 4.2%), but fewer discontinued for adverse events (4.2% vs 13.6%). In a post hoc reanalysis excluding 107 patients (15%) with non-R5 screening virus by the current, more sensitive tropism assay, the lower bound of the 1-sided 97.5% confidence interval for the difference between treatment groups was above -10% for each end point.
CONCLUSIONS: Twice-daily maraviroc was not noninferior to efavirenz at <50 copies/mL in the primary analysis. However, 15% of patients would have been ineligible for inclusion by a more sensitive screening assay. Their retrospective exclusion resulted in similar response rates in both arms Trial registration. identifier: (NCT00098293) .
David A Cooper; Jayvant Heera; James Goodrich; Margaret Tawadrous; Michael Saag; Edwin Dejesus; Nathan Clumeck; Sharon Walmsley; Naitee Ting; Eoin Coakley; Jacqueline D Reeves; Gustavo Reyes-Teran; Mike Westby; Elna Van Der Ryst; Prudence Ive; Lerato Mohapi; Horacio Mingrone; Andrzej Horban; Frances Hackman; John Sullivan; Howard Mayer
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Publication Detail:
Type:  Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  201     ISSN:  1537-6613     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-22     Completed Date:  2010-03-30     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  803-13     Citation Subset:  AIM; IM    
Data Bank Information
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MeSH Terms
Anti-HIV Agents / pharmacology*,  standards
Anti-Retroviral Agents
Antiviral Agents / pharmacology
Benzoxazines / pharmacology,  standards,  therapeutic use*
Cyclohexanes / pharmacology,  standards,  therapeutic use*
Double-Blind Method
Drug Combinations
Drug Resistance, Viral
Drug Therapy, Combination
HIV Infections / drug therapy*
HIV-1 / drug effects*,  physiology
Lamivudine / administration & dosage
Middle Aged
Receptors, CCR5 / antagonists & inhibitors*,  metabolism
Treatment Outcome
Triazoles / pharmacology,  standards,  therapeutic use*
Viral Load
Viral Tropism
Young Adult
Zidovudine / administration & dosage
Reg. No./Substance:
0/Anti-HIV Agents; 0/Anti-Retroviral Agents; 0/Antiviral Agents; 0/Benzoxazines; 0/Cyclohexanes; 0/Drug Combinations; 0/Receptors, CCR5; 0/Triazoles; 2T8Q726O95/Lamivudine; 4B9XT59T7S/Zidovudine; JE6H2O27P8/efavirenz; MD6P741W8A/maraviroc
Comment In:
J Infect Dis. 2010 Mar 15;201(6):797-9   [PMID:  20151843 ]

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