PMID- 21126956
OWN - NLM
STAT- MEDLINE
DCOM- 20110106
LR  - 20151119
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 11
IP  - 5
DP  - 2010 Sep-Oct
TI  - A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive 
      HIV-1-infected patients: 48-week results of the SHIELD trial.
PG  - 260-9
LID - 10.1310/hct1105-260 [doi]
AB  - PURPOSE: to evaluate raltegravir plus abacavir/lamivudine in 
      antiretroviral-naive, HIV-1-infected patients. METHODS: SHIELD is an ongoing 
      96-week pilot study of abacavir/lamivudine 600 mg/300 mg once daily with 
      raltegravir 400 mg twice daily among HLA-B*5701-negative adults with screening 
      viral load (VL) > 1,000 copies/mL. HBsAg+ patients were excluded, as were 
      patients with key mutation(s) to any study drug. Virologic failure (VF) was 
      defined as either VL > 400 copies/mL at week 24 or confirmed virologic rebound. 
      RESULTS: thirty-five patients enrolled (mean age 38.7 years). Most were white 
      males, but 26% self-identified as Hispanic/Latino. At baseline, 34% had VL >/= 
      100,000 copies/mL (median, 4.8 log10 copies/mL) and 20% had CD4 cell counts <200 
      cells/mm3 (median, 301). One patient discontinued due to adverse events (AEs); 
      one patient experienced VF. At week 48, 91% (32/35) had VL <50 and <400 copies/mL 
      by missing/discontinuation equals failure analysis. Median CD4 cell count change 
      from baseline was +247 cells/mm3. Five patients (14%) had treatment-related grade 
      2-4 AEs; no treatment-related serious AEs were reported. Over 48 weeks, median 
      fasting lipids increased for total (+17%), LDL (+9%), and HDL (+6%) cholesterol 
      but remained stable for triglycerides (-1%) and total:HDL cholesterol ratio (0%). 
      CONCLUSIONS: in this pilot study, abacavir/lamivudine plus raltegravir was 
      effective and generally well-tolerated over 48 weeks with modest changes in 
      fasting lipids.
FAU - Young, Benjamin
AU  - Young B
AD  - Rocky Mountain CARES, Denver, Colorado, USA Health Connections International, 
      Amsterdam, The Netherlands. byoung@rockymountaincares.org
FAU - Vanig, Thanes
AU  - Vanig T
FAU - Dejesus, Edwin
AU  - Dejesus E
FAU - Hawkins, Trevor
AU  - Hawkins T
FAU - St Clair, Marty
AU  - St Clair M
FAU - Yau, Linda
AU  - Yau L
FAU - Ha, Belinda
AU  - Ha B
FAU - Shield Study Team
AU  - Shield Study Team
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Dideoxynucleosides)
RN  - 0 (Drug Combinations)
RN  - 0 (Interleukin-6)
RN  - 0 (Pyrrolidinones)
RN  - 0 (RNA, Viral)
RN  - 0 (Triglycerides)
RN  - 0 (abacavir, lamivudine drug combination)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 43Y000U234 (Raltegravir Potassium)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - 97C5T2UQ7J (Cholesterol)
SB  - IM
CIN - HIV Clin Trials. 2011 Jul-Aug;12(4):228-33. PMID: 22044859
MH  - Adult
MH  - C-Reactive Protein/metabolism
MH  - CD4 Lymphocyte Count
MH  - Cholesterol/blood
MH  - Dideoxynucleosides/*administration & dosage
MH  - Drug Combinations
MH  - Female
MH  - HIV Infections/blood/*drug therapy/virology
MH  - *HIV-1
MH  - Humans
MH  - Interleukin-6/blood
MH  - Lamivudine/*administration & dosage
MH  - Male
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Pyrrolidinones/*administration & dosage
MH  - RNA, Viral/blood
MH  - Raltegravir Potassium
MH  - Triglycerides/blood
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 - 07142184825U2164 [pii]
AID - 10.1310/hct1105-260 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.