PMID- 21083412
OWN - NLM
STAT- MEDLINE
DCOM- 20101221
LR  - 20201209
IS  - 1931-8405 (Electronic)
IS  - 0889-2229 (Linking)
VI  - 26
IP  - 11
DP  - 2010 Nov
TI  - A 48-week pilot study switching suppressed patients to darunavir/ritonavir and 
      etravirine from enfuvirtide, protease inhibitor(s), and non-nucleoside reverse 
      transcriptase inhibitor(s).
PG  - 1215-9
LID - 10.1089/aid.2009.0285 [doi]
AB  - Treatment options for HIV-infected patients can be limited due to viral drug 
      resistance to antiretroviral agents. Enfuvirtide (ENF) is an injectable 
      entry/fusion inhibitor that is effective in achieving viral suppression when used 
      in combination with protease inhibitors (PIs) in patients with pre-existing 
      resistance. However, ENF treatment is associated with injection site reactions 
      and dosing fatigue. This multicenter, open-label, Phase IIIb, 48-week pilot study 
      assessed safety, tolerability, and effectiveness of the PI darunavir (DRV), 
      boosted with ritonavir (DRV/r), and the non-nucleoside reverse transcriptase 
      inhibitor (NNRTI) etravirine (ETR), when substituted for ENF/PI (+/-NNRTI)-based 
      therapy. Ten virologically suppressed (HIV RNA less than 50 copies/ml) men who 
      were intolerant to ENF were enrolled. Median (range) CD4+ count was 301 (187-663) 
      cells/mm(3). Two patients discontinued the study; all remaining patients 
      maintained a viral load of less than 50 copies/ml at Week 48. Viral load 
      increased to greater than 50 copies/ml in two patients, but was eventually 
      re-suppressed without the need for changes in treatment. Median (range) increase 
      (last observation carried forward) in CD4+ count from baseline to Week 48 was 64 
      (-53-100) cells/mm(3). Two grade 3 adverse events (AEs), nausea and weight loss, 
      and one serious AE, acute cholecystitis, were reported; each AE resolved without 
      treatment interruption. Most common AEs related to study drug were fatigue, rash, 
      headache, and diarrhea. Decreases in triglycerides, low-density lipoprotein, and 
      high-density lipoprotein, were observed. This study suggests that a DRV/r- and 
      ETR-based regimen can be substituted for an ENF-based regimen while maintaining 
      virologic suppression.
FAU - Ruane, Peter
AU  - Ruane P
AD  - Light Source Medical, Los Angeles, California 90036, USA. 
      pjruane@lightsourcemedical.com
FAU - Alas, Brian
AU  - Alas B
FAU - Ryan, Robert
AU  - Ryan R
FAU - Perniciaro, Amy
AU  - Perniciaro A
FAU - Witek, James
AU  - Witek J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - AIDS Res Hum Retroviruses
JT  - AIDS research and human retroviruses
JID - 8709376
RN  - 0 (Anti-HIV Agents)
RN  - 0 (HIV Envelope Protein gp41)
RN  - 0 (Nitriles)
RN  - 0 (Peptide Fragments)
RN  - 0 (Pyridazines)
RN  - 0 (Pyrimidines)
RN  - 0 (RNA, Viral)
RN  - 0 (Sulfonamides)
RN  - 0C50HW4FO1 (etravirine)
RN  - 19OWO1T3ZE (Enfuvirtide)
RN  - EC 2.7.7.49 (HIV Reverse Transcriptase)
RN  - EC 3.4.23.- (HIV Protease)
RN  - O3J8G9O825 (Ritonavir)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage/adverse effects
MH  - Antiretroviral Therapy, Highly Active/adverse effects/*methods
MH  - CD4 Lymphocyte Count
MH  - Darunavir
MH  - Enfuvirtide
MH  - HIV Envelope Protein gp41/*administration & dosage/adverse effects
MH  - HIV Infections/*drug therapy
MH  - HIV Protease/metabolism
MH  - HIV Reverse Transcriptase/antagonists & inhibitors
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Peptide Fragments/*administration & dosage/adverse effects
MH  - Pilot Projects
MH  - Pyridazines/*administration & dosage/adverse effects
MH  - Pyrimidines
MH  - RNA, Viral/blood
MH  - Ritonavir/*administration & dosage/adverse effects
MH  - Sulfonamides/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Viral Load
EDAT- 2010/11/19 06:00
MHDA- 2010/12/22 06:00
CRDT- 2010/11/19 06:00
PHST- 2010/11/19 06:00 [entrez]
PHST- 2010/11/19 06:00 [pubmed]
PHST- 2010/12/22 06:00 [medline]
AID - 10.1089/aid.2009.0285 [doi]
PST - ppublish
SO  - AIDS Res Hum Retroviruses. 2010 Nov;26(11):1215-9. doi: 10.1089/aid.2009.0285.