Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection.

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
Abstract/OtherAbstract:	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. ClinicalTrials.gov identifier: (NCT00098293) .

Authors:	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: 2010-05-17
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
Affiliation:	University of New South Wales, Sydney, Australia.
Data Bank Information
Bank Name/Acc. No.:	ClinicalTrials.gov/NCT00098293
Export Citation:	APA/MLA Format Download EndNote Download BibTex
MeSH Terms
Descriptor/Qualifier:	Adolescent Adult Aged 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 Female HIV Infections / drug therapy* HIV-1 / drug effects, physiology Humans Lamivudine / administration & dosage Male Middle Aged Receptors, CCR5 / antagonists & inhibitors, metabolism Treatment Outcome Triazoles / pharmacology, standards, therapeutic use* Viral Load Viral Tropism Young Adult Zidovudine / administration & dosage
Chemical
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; 0/maraviroc; 134678-17-4/Lamivudine; 154635-17-3/efavirenz; 30516-87-1/Zidovudine
Comments/Corrections
Comment In:	J Infect Dis. 2010 Mar 15;201(6):797-9 [PMID: 20151843 ]

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