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HIV Clinical Trials Volume 15, 2014 - Issue 5
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Original Articles

Dolutegravir: Clinical and Laboratory Safety in Integrase Inhibitor–Naive Patients

L. CurtisGlaxoSmithKlineStockley Park, UK;Correspondence[email protected]
,
G. NicholsGlaxoSmithKlineResearch Triangle Park, NC, USA;
,
C. StainsbyGlaxoSmithKlineStockley Park, UK;
,
J. LimGlaxoSmithKlineStockley Park, UK;
,
A. AylottGlaxoSmithKlineStockley Park, UK;
,
B. WynneGlaxoSmithKlinePhiladelphia, PA, USA;
,
A. ClarkViiV HealthcareBrentford, UK;
,
M BlochHoldsworth House Medical PracticeSydney, Australia;
,
G. MaechlerViiV HealthcareBrentford, UK;
,
L.. Martin-CarpenterViiV HealthcareResearch Triangle Park, NC, USA;
,
F. RaffiNantes University HospitalInfectious and Tropical Diseases Department, Nantes, France
&
S. MinGlaxoSmithKlineResearch Triangle Park, NC, USA;
 show all
Pages 199-208 | Published online: 22 Dec 2014

REFERENCES

  • Stellbrink H-J, Reynes J, Lazzarin A, et al. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS. 2013;27: 1771–1778.
  • Raffi F, Rachlis A, Stellbrink H-J, et al; for the SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381:735–743.
  • Walmsley SL, Antela A, Clumeck N, et al; for the SIN-GLE Investigators. Dolutegravir plus abacavir—lamivu-dine for the treatment of HIV-1 infection. N Engl J Med. 2013;369:1807–1818.
  • Clotet B, Feinberg J, van Lunzen J, et al, on behalf of the ING114915 Study Team. Once-daily dolutegravir ver-sus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383:2222–2231.
  • Cahn P, Pozniak AL, Mingrone H, et al; for the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: Week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382:700–708.
  • Epzicom [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2012.
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  • Kastrup J, Petersen P, Bartram R, Hansen JM. The effect of trimethoprim on serum creatinine. Br J Urol. 1985;57: 265–268.
  • Koteff J, Borland J, Chen S, et al. A phase 1 study to eval-uate the effect of dolutegravir on renal function via mea-surement of iohexol and para-aminohippurate clearance in healthy subjects. Br J Clin Pharmacol. 2013;75:990–996.
  • Lepist El, Murray BP, Tong L, Roy A, Bannister R, Ray A. Effect of cobicistat and ritonavir on proximal renal tubular cell uptake and efflux transporters. Abstract presented at: 51st Interscience Conference on Antimicrobial Agents and Chemotherapy; September 2011; Denver, CO.
  • Song I, Borland J, Chen S, et al. Metabolism and drug-drug interaction profile of dolutegravir (DTG, S/GSK1349572). Abstract presented at: 13th International Workshop on Clinical Pharmacology of HIV Therapy; April 2012; Barce-lona, Spain.
  • Song I, Min SS, Borland J, et al. Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects. J Acquir Immune Defic Syndr. 2010;55:365–367.
  • Nichols G, Lazzarin A, Maggiolo F, et al. Phase 3 assessment of dolutegravir (DTG) 50 mg twice daily in HIV-1-infected subjects with raltegravir (RAL) and/or elvitegravir (EVG) resistance in VIKING-3: Week 24 results of all 183 patients enrolled. Abstract presented at: 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; July 2013; Kuala Lumpur, Malaysia.

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