PMID- 25777185
OWN - NLM
STAT- MEDLINE
DCOM- 20180122
LR  - 20201209
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 16
IP  - 1
DP  - 2015 Jan-Feb
TI  - The maraviroc expanded access program - safety and efficacy data from an 
      open-label study.
PG  - 10-21
LID - 10.1179/1528433614Z.0000000002 [doi]
AB  - PURPOSE: The maraviroc (MVC) expanded access program (EAP) was initiated to 
      increase MVC availability to patients with limited treatment options. Darunavir 
      (DRV), raltegravir (RAL), and etravirine (ETV) were either recently approved or 
      under regulatory review at study initiation and available for coadministration 
      with MVC. Thus, the safety of MVC in combination with new antiretroviral 
      therapies (ARVs) could be assessed. This open-label safety study of MVC was 
      conducted at 262 sites worldwide in 1032 R5 HIV-positive treatment-experienced 
      patients with limited/no therapeutic options. METHODS: Study visits included 
      screening, baseline, end of study or early discontinuation, and follow-up 30 days 
      after last dose. Interim visits for HIV-1 RNA and CD4 cell counts occurred 
      according to local HIV infection management guidelines. Safety data were analyzed 
      overall and by subgroup based on ARV combination [MVC+optimized background 
      therapy (OBT), MVC +/- OBT+DRV/r, MVC +/- OBT+RAL, MVC +/- OBT+RAL+DRV/r, 
      MVC +/- OBT+RAL+ETV +/- DRV/r]. RESULTS: Most (90.3%) adverse events (AEs) were of 
      mild or moderate severity with few grade 3/4 events, discontinuations, or 
      temporary discontinuations/dose reductions due to AEs or serious AEs. Similar 
      results were observed across subgroups. Of treated patients, 79.9% and 50% had 
      HIV-1 RNA < 400 copies/ml and < 50 copies/ml respectively, at the end of the 
      study, early termination visits, or at last known status. Tropism changes and 
      selection of MVC-resistant R5 virus, including high-level MVC dependence, were 
      mechanisms of viral escape. CONCLUSION: MVC was well tolerated with virologic 
      suppression observed in most patients.
FAU - Lazzarin, Adriano
AU  - Lazzarin A
FAU - Reynes, Jacques
AU  - Reynes J
FAU - Molina, Jean-Michel
AU  - Molina JM
FAU - Valluri, Srinivas
AU  - Valluri S
FAU - Mukwaya, Geoffrey
AU  - Mukwaya G
FAU - Heera, Jayvant
AU  - Heera J
FAU - Craig, Charles
AU  - Craig C
FAU - van der Ryst, Elna
AU  - van der Ryst E
FAU - Sierra-Madero, Juan G
AU  - Sierra-Madero JG
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20150123
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Anti-HIV Agents)
RN  - 0 (CCR5 Receptor Antagonists)
RN  - 0 (Cyclohexanes)
RN  - 0 (Nitriles)
RN  - 0 (Pyridazines)
RN  - 0 (Pyrimidines)
RN  - 0 (Triazoles)
RN  - 0C50HW4FO1 (etravirine)
RN  - 43Y000U234 (Raltegravir Potassium)
RN  - MD6P741W8A (Maraviroc)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-HIV Agents/therapeutic use
MH  - CCR5 Receptor Antagonists/*adverse effects/*therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Cyclohexanes/*adverse effects/*therapeutic use
MH  - Darunavir/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - *Health Services Accessibility
MH  - Humans
MH  - Male
MH  - Maraviroc
MH  - Middle Aged
MH  - Nitriles
MH  - Program Evaluation
MH  - Pyridazines/therapeutic use
MH  - Pyrimidines
MH  - Raltegravir Potassium/therapeutic use
MH  - Treatment Outcome
MH  - Triazoles/*adverse effects/*therapeutic use
MH  - Viral Load
MH  - Young Adult
OTO - NOTNLM
OT  - Antiretroviral agents
OT  - Darunavir,
OT  - Etravirine,
OT  - HIV,
OT  - Maraviroc,
OT  - Raltegravir,
EDAT- 2015/03/18 06:00
MHDA- 2015/03/18 06:01
CRDT- 2015/03/18 06:00
PHST- 2015/03/18 06:00 [entrez]
PHST- 2015/03/18 06:00 [pubmed]
PHST- 2015/03/18 06:01 [medline]
AID - 10.1179/1528433614Z.0000000002 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2015 Jan-Feb;16(1):10-21. doi: 10.1179/1528433614Z.0000000002. 
      Epub 2015 Jan 23.