PMID- 28369381
OWN - NLM
STAT- MEDLINE
DCOM- 20171107
LR  - 20181202
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 72
IP  - 6
DP  - 2017 Jun 1
TI  - Randomized controlled trial of the tolerability and completion of maraviroc 
      compared with Kaletra(R) in combination with Truvada(R) for HIV post-exposure 
      prophylaxis (MiPEP Trial).
PG  - 1760-1768
LID - 10.1093/jac/dkx062 [doi]
AB  - OBJECTIVES: Post-exposure prophylaxis (PEP) for HIV is often poorly tolerated and 
      not completed. Alternative PEP regimens may improve adherence and completion, 
      aiding HIV prevention. We conducted a randomized controlled trial of a 
      maraviroc-based PEP regimen compared with a standard-of-care regimen using 
      ritonavir-boosted lopinavir. METHODS: Patients meeting criteria for PEP were 
      randomized to tenofovir disoproxil/emtricitabine (200/245 mg) once daily plus 
      ritonavir-boosted lopinavir (Kaletra (R) 400/100 mg) or maraviroc 300 mg twice 
      daily. The composite primary endpoint was completion of 28 days of the allocated 
      PEP regimen without grade 3 or 4 clinical or laboratory adverse events (AEs) 
      related to the PEP medication. RESULTS: Two hundred and thirteen individuals were 
      randomized (107 to maraviroc; 106 to Kaletra (R) arm). Follow-up rates were high in 
      both groups. There was no difference in the primary endpoint; 70 (71%) in the 
      maraviroc and 64 (65%) in the Kaletra (R) arm ( P  =   0.36) completed PEP without 
      grade 3 or 4 AEs. Discontinuation of PEP was the same (18%) in both groups. There 
      were no grade 3 or 4 clinical AEs in either arm, but more grade 1 or 2 clinical 
      AEs in the Kaletra (R) arm (91% versus 70%; P  < 0.001). Antidiarrhoeal medication 
      use was higher in the Kaletra (R) arm (67% versus 25%; P  < 0.001). There were no 
      HIV seroconversions in the study period. CONCLUSIONS: The completion rate in the 
      absence of grade 3 or 4 AEs was similar with both regimens. Maraviroc-based PEP 
      was better tolerated, supporting its use as an option for non-occupational PEP.
CI  - (c) The Author 2017. Published by Oxford University Press on behalf of the British 
      Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, 
      please email: journals.permissions@oup.com.
FAU - Milinkovic, Ana
AU  - Milinkovic A
AD  - Centre for Sexual Health and HIV Research, University College London, UK.
FAU - Benn, Paul
AU  - Benn P
AD  - Central and North West London NHS Foundation Trust, The Mortimer Market Centre, 
      UK.
FAU - Arenas-Pinto, Alejandro
AU  - Arenas-Pinto A
AD  - Centre for Sexual Health and HIV Research, University College London, UK.
AD  - Central and North West London NHS Foundation Trust, The Mortimer Market Centre, 
      UK.
FAU - Brima, Nataliya
AU  - Brima N
AD  - Centre for Sexual Health and HIV Research, University College London, UK.
FAU - Copas, Andrew
AU  - Copas A
AD  - Centre for Sexual Health and HIV Research, University College London, UK.
FAU - Clarke, Amanda
AU  - Clarke A
AD  - The Claude Nicol Unit, Brighton and Sussex University Hospitals NHS Trust, 
      Brighton, UK.
FAU - Fisher, Martin
AU  - Fisher M
AD  - The Claude Nicol Unit, Brighton and Sussex University Hospitals NHS Trust, 
      Brighton, UK.
FAU - Schembri, Gabriel
AU  - Schembri G
AD  - Manchester Centre for Sexual Health, Manchester Royal Infirmary, Manchester, UK.
FAU - Hawkins, David
AU  - Hawkins D
AD  - Chelsea and Westminster NHS Foundation Trust, The John Hunter Clinic, London, UK.
FAU - Williams, Andy
AU  - Williams A
AD  - Royal London Hospital, Ambrose King Centre, London, UK.
FAU - Gilson, Richard
AU  - Gilson R
AD  - Centre for Sexual Health and HIV Research, University College London, UK.
AD  - Central and North West London NHS Foundation Trust, The Mortimer Market Centre, 
      UK.
CN  - MiPEP Trial Team
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Cyclohexanes)
RN  - 0 (Drug Combinations)
RN  - 0 (Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination)
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Triazoles)
RN  - 0 (lopinavir-ritonavir drug combination)
RN  - 2494G1JF75 (Lopinavir)
RN  - MD6P741W8A (Maraviroc)
RN  - O3J8G9O825 (Ritonavir)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/administration & dosage/adverse effects/*therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Cyclohexanes/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/administration & 
      dosage/adverse effects/*therapeutic use
MH  - Female
MH  - HIV Infections/drug therapy/*prevention & control/virology
MH  - HIV Protease Inhibitors/administration & dosage/adverse effects/therapeutic use
MH  - HIV-1/drug effects
MH  - Humans
MH  - Lopinavir/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Maraviroc
MH  - Medication Adherence
MH  - *Post-Exposure Prophylaxis
MH  - Ritonavir/administration & dosage/adverse effects/*therapeutic use
MH  - Triazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Young Adult
EDAT- 2017/04/04 06:00
MHDA- 2017/11/08 06:00
CRDT- 2017/04/04 06:00
PHST- 2016/11/15 00:00 [received]
PHST- 2017/02/06 00:00 [accepted]
PHST- 2017/04/04 06:00 [pubmed]
PHST- 2017/11/08 06:00 [medline]
PHST- 2017/04/04 06:00 [entrez]
AID - 3076248 [pii]
AID - 10.1093/jac/dkx062 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2017 Jun 1;72(6):1760-1768. doi: 10.1093/jac/dkx062.