PMID- 21126954
OWN - NLM
STAT- MEDLINE
DCOM- 20110106
LR  - 20201209
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 11
IP  - 5
DP  - 2010 Sep-Oct
TI  - Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg 
      or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial.
PG  - 239-47
LID - 10.1310/hct1105-239 [doi]
AB  - PURPOSE: ritonavir (RTV) effectively boosts most protease inhibitors but is 
      associated with significant dose-dependent adverse events (AEs). In an effort to 
      better manage toxicities through a reduced dose of RTV, this study compared 
      fosamprenavir (FPV) boosted with RTV 100 mg (FPV/r100) or with RTV 200 mg 
      (FPV/r200) daily. METHODS: this 24-week, open-label study enrolled patients 
      taking a FPV/r 200-containing regimen who had HIV RNA <400 copies/mL and 
      randomized them 1:2 to continue that regimen or simplify to FPV/r100 once daily. 
      Other medications were not altered. The primary endpoint was the percentage of 
      patients without suspected or confirmed virologic failure (HIV RNA >/= 400 
      copies/mL) through week 24 by a missing/discontinuation equals failure (M/D=F) 
      analysis. Noninferiority criteria were demonstrated if the lower bound of the 95% 
      confidence interval (CI) for the difference in the primary endpoint rates between 
      groups was greater than -12. RESULTS: the 2 regimens met prespecified 
      noninferiority criteria (FPV/r100, 92%; FPV/r 200, 94%; 95% CI, -9.36 to 5.12). 
      At week 24, the percentage of patients with HIV RNA <50 copies/mL by M/ D=F was 
      83% in the FPV/r100 group and 85% in the FPV/r 200 group. Drug-related grade 2-4 
      AEs were uncommon (FPV/r100, 4%; FPV/r 200, 7%). Median changes in lipids were 
      similar in both groups, with the exception of triglycerides (FPV/r100, -21 mg/dL; 
      FPV/r 200, -2 mg/dL). CONCLUSIONS: this 24-week study demonstrated that among 
      previously suppressed patients, once-daily FPV/r100 was similar to FPV/r 200 in 
      virologic and immunologic effects but was associated with greater decreases from 
      baseline in triglyceride levels.
FAU - Cohen, Calvin
AU  - Cohen C
AD  - Community Research Initiative of New England, Boston, Massachusetts, USA.
FAU - Dejesus, Edwin
AU  - Dejesus E
FAU - Lamarca, Anthony
AU  - Lamarca A
FAU - Young, Benjamin
AU  - Young B
FAU - Yau, Linda
AU  - Yau L
FAU - Patel, Lisa
AU  - Patel L
FAU - Vavro, Cindy
AU  - Vavro C
FAU - Wire, Mary Beth
AU  - Wire MB
FAU - Wannamaker, Paul
AU  - Wannamaker P
FAU - Shaefer, Mark
AU  - Shaefer M
LA  - eng
SI  - ClinicalTrials.gov/NCT00363142
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Carbamates)
RN  - 0 (Furans)
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Organophosphates)
RN  - 0 (RNA, Viral)
RN  - 0 (Sulfonamides)
RN  - 0 (Triglycerides)
RN  - 97C5T2UQ7J (Cholesterol)
RN  - O3J8G9O825 (Ritonavir)
RN  - WOU1621EEG (fosamprenavir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - CD4 Lymphocyte Count
MH  - Carbamates/*administration & dosage/adverse effects/pharmacokinetics
MH  - Cholesterol/blood
MH  - Dose-Response Relationship, Drug
MH  - Drug Synergism
MH  - Female
MH  - Furans
MH  - HIV Infections/blood/*drug therapy/virology
MH  - HIV Protease Inhibitors/adverse effects/pharmacokinetics/*therapeutic use
MH  - *HIV-1
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Organophosphates/*administration & dosage/adverse effects/pharmacokinetics
MH  - RNA, Viral/blood
MH  - Ritonavir/*administration & dosage/adverse effects/pharmacokinetics
MH  - Sulfonamides/*administration & dosage/adverse effects/pharmacokinetics
MH  - Triglycerides/blood
MH  - Young Adult
EDAT- 2010/12/04 06:00
MHDA- 2011/01/07 06:00
CRDT- 2010/12/04 06:00
PHST- 2010/12/04 06:00 [entrez]
PHST- 2010/12/04 06:00 [pubmed]
PHST- 2011/01/07 06:00 [medline]
AID - 03T2627460QT57XG [pii]
AID - 10.1310/hct1105-239 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2010 Sep-Oct;11(5):239-47. doi: 10.1310/hct1105-239.