PMID- 25276665
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141003
LR  - 20211021
IS  - 2248-2997 (Print)
IS  - 2248-2997 (Electronic)
IS  - 2248-2997 (Linking)
VI  - 4
IP  - 3
DP  - 2014 Sep
TI  - Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other 
      antiretroviral medications in subtype F HIV-1 infected, treatment-experienced 
      subjects in Romania: a post-authorization, open-label, one-cohort, 
      non-interventional, prospective study.
PG  - 59-69
LID - 10.11599/germs.2014.1057 [doi]
AB  - INTRODUCTION: The aim of the study was to assess the safety and efficacy of 
      darunavir (Prezista((R))) used in subtype F human immunodeficiency virus - type 1 
      (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in 
      routine clinical practice. METHODS: This was a post-authorization, open-label, 
      one-cohort, non-interventional, prospective study conducted at multiple sites in 
      Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) 
      and safety ([serious] adverse events, clinical laboratory evaluation, and vital 
      signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other 
      antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in 
      naturalistic settings. Seventy-eight subjects were recruited by 9 investigational 
      sites and received 600/100 mg DRV/r twice daily. RESULTS: Treatment with DRV/r 
      administered with other ARV medications resulted in the expected, statistically 
      relevant improvement of CD4 cell count and viral load in subjects eligible for 
      such treatment. In addition, adherence to treatment was high and the 
      treatment-emergent safety profile observed during this study was consistent with 
      the established safety profile of darunavir. CONCLUSION: DRV/r administered in 
      combination with other ARV medications in subtype F HIV-1 infected subjects in 
      naturalistic settings proved to be an effective and safe treatment in Romania. 
      TRIAL REGISTRATION: NCT01253967.
FAU - Benea, Otilia Elisabeta
AU  - Benea OE
AD  - MD, PhD, Associate Professor, Department of Infectious Diseases, Carol Davila 
      University of Medicine and Pharmacy; National Institute for Infectious Diseases 
      "Prof. Dr. Matei Bals", Bucharest, Romania.
FAU - Streinu-Cercel, Adrian
AU  - Streinu-Cercel A
AD  - MD, PhD, Professor, Department of Infectious Diseases, Carol Davila University of 
      Medicine and Pharmacy; National Institute for Infectious Diseases "Prof.Dr. Matei 
      Bals", Bucharest, Romania.
FAU - Dorobat, Carmen
AU  - Dorobat C
AD  - MD, PhD, Professor, Clinic of Infectious Diseases, "Gr.T.Popa" University of 
      Medicine and Pharmacy, Iasi, Romania.
FAU - Rugina, Sorin
AU  - Rugina S
AD  - MD, PhD, Professor, Ovidius University of Constanta; Clinical Hospital of 
      Infectious Diseases, Constanta, Romania.
FAU - Negrutiu, Lucian
AU  - Negrutiu L
AD  - MD, PhD, Professor, Head of I-st Clinic of Infectious Diseases, Timisoara, 
      Romania.
FAU - Cupsa, Augustin
AU  - Cupsa A
AD  - MD, PhD, Professor, Clinical Hospital of Infectious Diseases "Victor Babes" 
      Craiova, Romania.
FAU - Duiculescu, Dan
AU  - Duiculescu D
AD  - MD, PhD, "Dr. Victor Babes" Hospital for Infectious and Tropical Diseases, 
      Bucharest, Romania.
FAU - Chiriac, Carmen
AU  - Chiriac C
AD  - MD, PhD, Senior Lecturer, University of Medicine and Pharmacy Tirgu-Mures, 
      Department of Infectious Diseases, Tirgu-Mures, Romania.
FAU - Itu, Corina
AU  - Itu C
AD  - MD, PhD, Clinical Hospital of Infectious Diseases, Cluj-Napoca, Romania.
FAU - Prisacariu, Liviu Jany
AU  - Prisacariu LJ
AD  - MD, Clinic of Infectious Diseases, "Gr.T.Popa" University of Medicine and 
      Pharmacy, Iasi, Romania.
FAU - Iosif, Ionel
AU  - Iosif I
AD  - MD, Epidemiology, Drug Trial Design, Bioequivalence and Biodistribution Studies, 
      Bucharest, Romania.
LA  - eng
SI  - ClinicalTrials.gov/NCT01253967
PT  - Journal Article
DEP - 20140901
PL  - Romania
TA  - Germs
JT  - Germs
JID - 101596099
PMC - PMC4176257
OTO - NOTNLM
OT  - Darunavir
OT  - HIV-1
OT  - antiretroviral therapy
OT  - efficacy
OT  - prospective study
OT  - ritonavir
OT  - safety
COIS- Conflicts of interest Prof. Dr. Augustin Cupsa received honoraria as coordinating 
      and principal investigator in the Sperante study from Johnson & Johnson Romania 
      Medical Affairs. He is occasionally consultant in advisory boards for Abbott, 
      MSD, Roche, GSK, J&J, BMS Romanian local branches and sometimes speaker for the 
      same groups.
EDAT- 2014/10/03 06:00
MHDA- 2014/10/03 06:01
PMCR- 2014/09/01
CRDT- 2014/10/03 06:00
PHST- 2014/04/10 00:00 [received]
PHST- 2014/06/20 00:00 [revised]
PHST- 2014/07/14 00:00 [accepted]
PHST- 2014/10/03 06:00 [entrez]
PHST- 2014/10/03 06:00 [pubmed]
PHST- 2014/10/03 06:01 [medline]
PHST- 2014/09/01 00:00 [pmc-release]
AID - germs.2014.1057 [pii]
AID - 10.11599/germs.2014.1057 [doi]
PST - epublish
SO  - Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 
      Sep.