|Maraviroc once-daily nucleoside analog-sparing regimen in treatment-naive patients: randomized, open-label pilot study.|
|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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|Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't|
|Title: Journal of acquired immune deficiency syndromes (1999) Volume: 62 ISSN: 1944-7884 ISO Abbreviation: J. Acquir. Immune Defic. Syndr. Publication Date: 2013 Feb|
|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|
|Languages: eng Pagination: 164-70 Citation Subset: IM; X|
|APA/MLA Format Download EndNote Download BibTex|
analogs & derivatives,
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
Oligopeptides / therapeutic use
Organophosphonates / therapeutic use
Pyridines / therapeutic use
RNA, Viral / blood*
Receptors, CCR5 / antagonists & inhibitors
Ritonavir / therapeutic use
Triazoles / adverse effects, pharmacokinetics, therapeutic use*
|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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