A phase 1 study to evaluate the effect of dolutegravir on renal function via measurement of iohexol and para-aminohippurate clearance in healthy subjects

British Journal of Clinical Pharmacology

Volumn 75, Issue 4, 2013, Pages 990-996

  Koteff, Justin ^a   Borland, Julie ^b   Chen, Shuguang ^b   Song, Ivy ^b   Peppercorn, Amanda ^b   Koshiba, Takaaki ^c   Cannon, Courtney ^d   Muster, Heather ^d   Piscitelli, Stephen C ^b  

^a VIIV HEALTHCARE   (United States)

^b GLAXOSMITHKLINE   (United States)

^c SHIONOGI AND CO LTD   (Japan)

^d DAVITA CLINICAL RESEARCH   (United States)

Author keywords

Creatinine clearance; Dolutegravir (DTG; Glomerular filtration rate; HIV integrase; Iohexol; S GSK1349572)

Indexed keywords

CREATININE; DOLUTEGRAVIR;

4 AMINOHIPPURIC ACID CLEARANCE; ADULT; AGED; APPETITE DISORDER; AREA UNDER THE CURVE; ARTICLE; BICARBONATE BLOOD LEVEL; CONJUNCTIVAL HYPEREMIA; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DECREASED APPETITE; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG TOLERABILITY; DRUG URINE LEVEL; DRUG WITHDRAWAL; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; HUMAN EXPERIMENT; IOHEXOL PLASMA CLEARANCE; KIDNEY FUNCTION; MALE; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMA CLEARANCE; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; UNSPECIFIED SIDE EFFECT; UREA NITROGEN BLOOD LEVEL;

ADOLESCENT; ADULT; AGED; CREATININE; FEMALE; GLOMERULAR FILTRATION RATE; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INTEGRASE INHIBITORS; HUMANS; IOHEXOL; MALE; MIDDLE AGED; P-AMINOHIPPURIC ACID; RENAL PLASMA FLOW;

EID: 84874431501     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04440.x     Document Type: Article

References (14)

1. Burkhardt H, Bojarsky G, Gretz N, Gladisch R. Creatinine clearance, Cockcroft-Gault formula and cystatin C: estimators of true glomerular filtration rate in the elderly? Gerontology 2002; 48: 140-146.
2. Urakami Y, Kimura N, Okuda M, Inui K. Creatinine transport by basolateral organic cation transporter hOCT2 in the human kidney. Pharm Res 2004; 21: 976-981.
3. Urakami Y, Kimura N, Okuda M, Masuda S, Katsura T, Inui K. Transcellular transport of creatinine in renal tubular epithelial cell line LLC-PK1. Drug Metab Pharmacokinet 2005; 20: 200-205.
4. Min S, Song I, Borland J, Chen S, Lou Y, Fukiwara T, Piscitelli SC. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother 2010; 54: 254-258.
5. Van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomized, phase 2b trial. Lancet Infect Dis 2011; 12: 111-118.
6. Min S, Carrod A, Curtis L, Stainsby C, Brothers C, Yeo J, Nichols G. Safety profile of dolutegravir (DTG, S/GSK1349572), in combination with other antiretrovirals in antiretroviral (ART)-naive and ART-experienced adults from two phase IIb studies. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. July 17-20, 2011. Rome, Italy. Abstract TUPE238. Available at http://pag.ias2011.org/abstracts.aspx?aid=2883 (last accessed 24 April 2012).
7. Andreev E, Koopman M, Arisz L. A rise in plasma creatinine that is not a sign of renal failure: which drugs can be responsible? J Intern Med 1999; 246: 247-252.
8. Burgess E, Blair A, Krichman K, Cutler RE. Inhibition of renal creatinine secretion by cimetidine in humans. Ren Physiol 1982; 5: 27-30.
9. Koteff J, Borland J, Chen S, Song I, Peppercorn A, Koshiba T, Cannon C, Muster H, Piscitelli S. An open label, placebo-controlled study to evaluate the effect of dolutegravir (DTG, S/GSK1349572) on iohexol and para-aminohippurate clearance in healthy subjects. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). September 17-20, 2011. Chicago, IL. Abstract A1-1728. Available at http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=0b498641-f10a-4936-b80c-d274ffe4b143&cKey=3a0c1f0c-f7e6-49e8-ab05-1f798d21d369&mKey=0C918954-D607-46A7-8073-44F4B537A439 (last accessed 24 April 2012).
10. Ginsberg AM, Laurenz MW, Rouse DJ, Whitney KD, Spigelman MK. Assessment of the effects of the nitroimidazo-oxazine PA-824 on renal function in healthy subjects. Antimicrob Agents Chemother 2009; 53: 3726-3733.
11. Gaspari F, Perico N, Ruggenenti P, Mosconi L, Amuchastegui CS, Guerini E, Daina E, Remuzzi G. Plasma clearance of nonradioactive iohexol as a measure of glomerular filtration rate. J Am Soc Nephrol 1995; 6: 257-263.
12. Brown SC, O'Reilly PH. Iohexol clearance for the determination of glomerular filtration rate in clinical practice: evidence for a new gold standard. J Urol 1991; 146: 675-679.
13. Carroll MF, Temte JL. Proteinuria in adults: a diagnostic approach. Am Fam Physician 2000; 62: 1333-1340.
14. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis 2002; 39: (2 Suppl. 1): S1-266.