Document Detail

Maraviroc once-daily nucleoside analog-sparing regimen in treatment-naive patients: randomized, open-label pilot study.
MedLine Citation:
PMID:  23187936     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: This study was performed to evaluate a once-daily dual-therapy regimen, maraviroc (MVC) + atazanavir/ritonavir (ATV/r), in treatment-naive patients.
DESIGN: A phase 2b, randomized, open-label pilot study.
METHODS: In Study A4001078 (NCT00827112), treatment-naive patients with CCR5-tropic HIV-1 (HIV-1 RNA ≥1000 copies/mL; CD4 cell count ≥100 cells/mm) were randomized to receive either MVC 150 mg once daily (n = 60) or tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily (n = 61) + ATV/r 300/100 mg once daily. Primary endpoint was proportion of patients with HIV-1 RNA <50 copies per milliliter at week 48.
RESULTS: At week 48, 44 (74.6%) and 51 (83.6%) patients in the MVC and TDF/FTC treatment groups, respectively, had plasma HIV-1 RNA <50 copies per milliliter. Median change from baseline in CD4 cell count at week 48 was +173 and +187 cells per cubic millimeter with MVC and TDF/FTC, respectively. Seven patients discontinued from each arm; there were no deaths. The incidence of serious adverse events (AEs) was similar in each group; however, there were more grade 3/4 AEs in the MVC group (18 vs 11), mostly due to hyperbilirubinemia. Three patients in each arm were evaluable for virological analysis at discontinuation or failure (HIV-1 RNA >500 copies/mL); no genotypic resistance, change in tropism, or loss of susceptibility relevant to treatment was observed.
CONCLUSIONS: The virological activity and immunological benefit of once-daily MVC + ATV/r were confirmed. Indirect hyperbilirubinemia and associated signs were the most commonly reported AEs in both study treatment groups and were not associated with significant transaminase increases. No drug resistance occurred.
Anthony Mills; Donna Mildvan; Daniel Podzamczer; Gerd Fätkenheuer; Manuel Leal; Soe Than; Srinivas R Valluri; Charles Craig; Lynn McFadyen; Manoli Vourvahis; Jayvant Heera; Hernan Valdez; Alex R Rinehart; Simon Portsmouth
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  62     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-18     Completed Date:  2013-03-08     Revised Date:  2013-11-25    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  164-70     Citation Subset:  IM; X    
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MeSH Terms
Adenine / analogs & derivatives,  therapeutic use
Anti-HIV Agents / therapeutic use
CD4 Lymphocyte Count
Cyclohexanes / adverse effects,  pharmacokinetics,  therapeutic use*
Deoxycytidine / analogs & derivatives,  therapeutic use
Drug Therapy, Combination / adverse effects
HIV Fusion Inhibitors / adverse effects,  pharmacokinetics,  therapeutic use*
HIV Infections / drug therapy*,  immunology
Middle Aged
Oligopeptides / therapeutic use
Organophosphonates / therapeutic use
Pilot Projects
Pyridines / therapeutic use
RNA, Viral / blood*
Receptors, CCR5 / antagonists & inhibitors
Ritonavir / therapeutic use
Triazoles / adverse effects,  pharmacokinetics,  therapeutic use*
Viral Load
Young Adult
Reg. No./Substance:
0/Anti-HIV Agents; 0/Cyclohexanes; 0/HIV Fusion Inhibitors; 0/Oligopeptides; 0/Organophosphonates; 0/Pyridines; 0/RNA, Viral; 0/Receptors, CCR5; 0/Triazoles; 0/emtricitabine; 0W860991D6/Deoxycytidine; 107021-12-5/tenofovir; JAC85A2161/Adenine; MD6P741W8A/maraviroc; O3J8G9O825/Ritonavir; QZU4H47A3S/atazanavir

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

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