PMID- 23187936
OWN - NLM
STAT- MEDLINE
DCOM- 20130308
LR  - 20200930
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Linking)
VI  - 62
IP  - 2
DP  - 2013 Feb 1
TI  - Maraviroc once-daily nucleoside analog-sparing regimen in treatment-naive 
      patients: randomized, open-label pilot study.
PG  - 164-70
LID - 10.1097/QAI.0b013e31827b51b5 [doi]
AB  - 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.
FAU - Mills, Anthony
AU  - Mills A
AD  - Anthony Mills MD Inc., Los Angeles, CA, USA.
FAU - Mildvan, Donna
AU  - Mildvan D
FAU - Podzamczer, Daniel
AU  - Podzamczer D
FAU - Fatkenheuer, Gerd
AU  - Fatkenheuer G
FAU - Leal, Manuel
AU  - Leal M
FAU - Than, Soe
AU  - Than S
FAU - Valluri, Srinivas R
AU  - Valluri SR
FAU - Craig, Charles
AU  - Craig C
FAU - McFadyen, Lynn
AU  - McFadyen L
FAU - Vourvahis, Manoli
AU  - Vourvahis M
FAU - Heera, Jayvant
AU  - Heera J
FAU - Valdez, Hernan
AU  - Valdez H
FAU - Rinehart, Alex R
AU  - Rinehart AR
FAU - Portsmouth, Simon
AU  - Portsmouth S
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-HIV Agents)
RN  - 0 (CCR5 Receptor Antagonists)
RN  - 0 (Cyclohexanes)
RN  - 0 (HIV Fusion Inhibitors)
RN  - 0 (Oligopeptides)
RN  - 0 (Organophosphonates)
RN  - 0 (Pyridines)
RN  - 0 (RNA, Viral)
RN  - 0 (Triazoles)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 4MT4VIE29P (Atazanavir Sulfate)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JAC85A2161 (Adenine)
RN  - MD6P741W8A (Maraviroc)
RN  - O3J8G9O825 (Ritonavir)
SB  - IM
MH  - Adenine/analogs & derivatives/therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-HIV Agents/therapeutic use
MH  - Atazanavir Sulfate
MH  - CCR5 Receptor Antagonists
MH  - CD4 Lymphocyte Count
MH  - Cyclohexanes/adverse effects/pharmacokinetics/*therapeutic use
MH  - Deoxycytidine/analogs & derivatives/therapeutic use
MH  - Drug Therapy, Combination/adverse effects
MH  - Emtricitabine
MH  - Female
MH  - HIV Fusion Inhibitors/adverse effects/pharmacokinetics/*therapeutic use
MH  - HIV Infections/*drug therapy/immunology
MH  - *HIV-1
MH  - Humans
MH  - Male
MH  - Maraviroc
MH  - Middle Aged
MH  - Oligopeptides/therapeutic use
MH  - Organophosphonates/therapeutic use
MH  - Pilot Projects
MH  - Pyridines/therapeutic use
MH  - RNA, Viral/*blood
MH  - Ritonavir/therapeutic use
MH  - Tenofovir
MH  - Triazoles/adverse effects/pharmacokinetics/*therapeutic use
MH  - Viral Load
MH  - Young Adult
EDAT- 2012/11/29 06:00
MHDA- 2013/03/09 06:00
CRDT- 2012/11/29 06:00
PHST- 2012/11/29 06:00 [entrez]
PHST- 2012/11/29 06:00 [pubmed]
PHST- 2013/03/09 06:00 [medline]
AID - 10.1097/QAI.0b013e31827b51b5 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2013 Feb 1;62(2):164-70. doi: 
      10.1097/QAI.0b013e31827b51b5.