PMID- 16280695
OWN - NLM
STAT- MEDLINE
DCOM- 20060110
LR  - 20200930
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 40
IP  - 4
DP  - 2005 Dec 1
TI  - Safety of enfuvirtide in combination with an optimized background of 
      antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks.
PG  - 413-21
AB  - BACKGROUND: Antiretroviral tolerability is a critical factor contributing to 
      treatment outcome. The T-20 Versus Optimized Background Regimen Only (TORO) 
      studies assessed the safety and efficacy of enfuvirtide in treatment-experienced 
      HIV-1-infected patients. METHODS: A total of 997 patients were randomized at a 
      2:1 ratio to an optimized background antiretroviral regimen plus enfuvirtide (n = 
      663) or an optimized background regimen alone (control group; n = 334). Control 
      patients could switch to enfuvirtide on virologic failure. RESULTS: In total, 
      26.5% of patients randomized to enfuvirtide and 36.6% to the control group 
      discontinued study treatment before week 48; the percentage of patients withdrawn 
      for safety reasons (including adverse events [AEs], deaths, and laboratory 
      abnormalities) was 14.0% in the enfuvirtide group and 11.6% in the control group. 
      Injection site reactions (ISRs) occurred in 98% of enfuvirtide patients and led 
      to treatment discontinuation in 4.4%. Treatment-related (defined as possibly, 
      probably, or remotely) AE rates per 100 patient-years were lower with enfuvirtide 
      (96.2) than in the control group (149.9); diarrhea, nausea, and fatigue, the most 
      frequently reported AEs, were significantly less frequent with enfuvirtide than 
      in the control group. Pneumonia was significantly more frequent in patients 
      treated with enfuvirtide (6.7 vs. 0.6 events per 100 patient-years), although the 
      incidence was within expected ranges for this population. Lymphadenopathy was 
      also higher in enfuvirtide-treated patients (7.1 vs. 1.2 events per 100 
      patient-years) for control patients. CONCLUSION: The addition of enfuvirtide to 
      an optimized background regimen does not exacerbate AEs commonly associated with 
      antiretrovirals. ISRs limited treatment in <5% of patients.
FAU - Trottier, Benoit
AU  - Trottier B
AD  - Clinique Medicale l'Actuel, Montreal, Quebec, Canada. trottier@lactuel.ca
FAU - Walmsley, Sharon
AU  - Walmsley S
FAU - Reynes, Jacques
AU  - Reynes J
FAU - Piliero, Peter
AU  - Piliero P
FAU - O'Hearn, Mary
AU  - O'Hearn M
FAU - Nelson, Mark
AU  - Nelson M
FAU - Montaner, Julio
AU  - Montaner J
FAU - Lazzarin, Adriano
AU  - Lazzarin A
FAU - Lalezari, Jacob
AU  - Lalezari J
FAU - Katlama, Christine
AU  - Katlama C
FAU - Henry, Keith
AU  - Henry K
FAU - Cooper, David
AU  - Cooper D
FAU - Clotet, Bonaventura
AU  - Clotet B
FAU - Arasteh, Keikawus
AU  - Arasteh K
FAU - Delfraissy, Jean-Francois
AU  - Delfraissy JF
FAU - Stellbrink, Hans-Jurgen
AU  - Stellbrink HJ
FAU - Lange, Joep
AU  - Lange J
FAU - Kuritzkes, Daniel
AU  - Kuritzkes D
FAU - Eron, Joseph J Jr
AU  - Eron JJ Jr
FAU - Cohen, Calvin
AU  - Cohen C
FAU - Kinchelow, Tosca
AU  - Kinchelow T
FAU - Bertasso, Anne
AU  - Bertasso A
FAU - Labriola-Tompkins, Emily
AU  - Labriola-Tompkins E
FAU - Shikhman, Anna
AU  - Shikhman A
FAU - Atkins, Belinda
AU  - Atkins B
FAU - Bourdeau, Laurence
AU  - Bourdeau L
FAU - Natale, Christopher
AU  - Natale C
FAU - Hughes, Fiona
AU  - Hughes F
FAU - Chung, Jain
AU  - Chung J
FAU - Guimaraes, Denise
AU  - Guimaraes D
FAU - Drobnes, Claude
AU  - Drobnes C
FAU - Bader-Weder, Silvia
AU  - Bader-Weder S
FAU - Demasi, Ralph
AU  - Demasi R
FAU - Smiley, Lynn
AU  - Smiley L
FAU - Salgo, Miklos P
AU  - Salgo MP
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
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 (HIV Envelope Protein gp41)
RN  - 0 (HIV Fusion Inhibitors)
RN  - 0 (Peptide Fragments)
RN  - 19OWO1T3ZE (Enfuvirtide)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/*therapeutic use
MH  - Diarrhea
MH  - Drug Therapy, Combination
MH  - Enfuvirtide
MH  - Fatigue
MH  - HIV Envelope Protein gp41/administration & dosage/*adverse effects/therapeutic 
      use
MH  - HIV Fusion Inhibitors/administration & dosage/*adverse effects/therapeutic use
MH  - HIV Infections/*drug therapy
MH  - *HIV-1
MH  - Humans
MH  - Lymphatic Diseases
MH  - Nausea
MH  - Peptide Fragments/administration & dosage/*adverse effects/therapeutic use
MH  - Pneumonia
EDAT- 2005/11/11 09:00
MHDA- 2006/01/13 09:00
CRDT- 2005/11/11 09:00
PHST- 2005/11/11 09:00 [pubmed]
PHST- 2006/01/13 09:00 [medline]
PHST- 2005/11/11 09:00 [entrez]
AID - 00126334-200512010-00005 [pii]
AID - 10.1097/01.qai.0000185313.48933.2c [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):413-21. doi: 
      10.1097/01.qai.0000185313.48933.2c.