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-
1
Mendis K, Sina BJ, Marchesini P, Carter R, 2001. The neglected burden of Plasmodium vivax malaria. Am J Trop Med Hyg 64 :97–106.
-
2
Price RN, Tjitra E, Guerra CA, Yeung S, White NJ, Anstey NM, 2007. Vivax malaria: neglected and not benign. Am J Trop Med Hyg 77 :79–87.
-
3
Baird JK, 2005. Effectiveness of antimalarial drugs. N Engl J Med 352 :1565–1577.
-
4
Crockett M, Kain KC, 2007. Tafenoquine: a promising new antimalarial agent. Expert Opin Investig Drugs 16 :705–715.
-
5
Peters W, 1999. The evolution of tafenoquine–antimalarial for a new millennium? J R Soc Med 92 :345–352.
-
6
World Health Organization, 2006. Guidelines for the Treatment of Malaria. Geneva, Switzerland, WHO. Available at: www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed September 4, 2007.
-
7
Walsh DS, Eamsila C, Sasiprapha T, Sangkharomya S, Khaewsathien P, Supakalin P, Tang DB, Jarasrumgsichol P, Cherdchu C, Edstein MD, Rieckmann KH, Brewer TG, 2004. Efficacy of monthly tafenoquine for prophylaxis of Plasmodium vivax and multidrug-resistant P. falciparum malaria. J Infect Dis 190 :1456–1463.
-
8
Walsh DS, Looareesuwan S, Wilairatana P, Heppner DG Jr, Tang DB, Brewer TG, Chokejindachai W, Viriyavejakul P, Kyle DE, Milhous WK, Schuster BG, Horton J, Braitman DJ, Brueckner RP, 1999. Randomized dose-ranging study of the safety and efficacy of WR 238605 (Tafenoquine) in the prevention of relapse of Plasmodium vivax malaria in Thailand. J Infect Dis 180 :1282–1287.
-
9
Melinda Gates Foundation, 2007. Eradication of Malaria. Available at: http://www.gatesfoundation.org/MediaCenter/Speeches/Co-ChairSpeeches/BillgSpeeches/BGSpeechMalariaForum-071017.htm. Accessed November 2007.
-
10
Nasveld P, Edstein M, Brennan L, 2008. Randomized, double-blind study of the safety, tolerability and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in non-immune subjects. Clin Infect Dis (submitted).
-
11
Barbur J, Harlow A, 1993. Colour vision testing using spatiotemporal luminance masking: psychophysical and pupillometric methods. Drum B, ed. Colour vision deficiencies XI. Proceedings of the Eleventh Symposium of the International Research Group on Colour Vision Deficiencies, Sydney, Australia, June 21–23, 1991. Dordrecht: Kluwer Academic Publishers, 417–426.
-
12
Bi D, Leary KJ, Weitz JA, Cherstniakova SA, Reil MA, Roy MJ, Cantilena LR, 2007. High performance liquid chromatographic measurement of iothalamate in human serum and urine for evaluation of glomerular filtration rate. J Chromatogr B Analyt Technol Biomed Life Sci 856 :95–99.
-
13
Dowling TC, Frye RF, Fraley DS, Matzke GR, 1999. Comparison of iothalamate clearance methods for measuring GFR. Pharmacotherapy 19 :943–950.
-
14
Gaspari F, Mosconi L, Vigano G, Perico N, Torre L, Virotta G, Bertocchi C, Remuzzi G, Ruggenenti P, 1992. Measurement of GFR with a single intravenous injection of nonradioactive iothalamate. Kidney Int 41 :1081–1084.
-
15
Clopper C, Pearson E, 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26 :404–413.
-
16
Anderson N, Borlak J, 2006. Drug-induced phospholipidosis. FEBS Lett 580 :5533–5540.
-
17
Jones SK, 1999. Ocular toxicity and hydroxychloroquine: guidelines for screening. Br J Dermatol 140 :3–7.
-
18
Lullmann H, Lullmann-Rauch R, Wassermann O, 1975. Drug-induced phospholipidoses. II. Tissue distribution of the amphiphilic drug chlorphentermine. CRC Crit Rev Toxicol 4 :185–218.
-
19
Brater DC, 2002. Measurement of renal function during drug development. Br J Clin Pharmacol 54 :87–95.
-
20
Kemperman FA, Surachno J, Krediet RT, Arisz L, 2002. Cimetidine improves prediction of the glomerular filtration rate by the Cockcroft-Gault formula in renal transplant recipients. Transplantation 73 :770–774.
-
21
Hale BR, Owusu-Agyei S, Fryauff DJ, Koram KA, Adjuik M, Oduro AR, Prescott WR, Baird JK, Nkrumah F, Ritchie TL, Franke ED, Binka FN, Horton J, Hoffman SL, 2003. A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum. Clin Infect Dis 36 :541–549.
-
22
Lell B, Faucher JF, Missinou MA, Borrmann S, Dangelmaier O, Horton J, Kremsner PG, 2000. Malaria chemoprophylaxis with tafenoquine: a randomised study. Lancet 355 :2041–2045.
-
23
Shanks GD, Oloo AJ, Aleman GM, Ohrt C, Klotz FW, Braitman D, Horton J, Brueckner R, 2001. A new primaquine analogue, tafenoquine (WR 238605), for prophylaxis against Plasmodium falciparum malaria. Clin Infect Dis 33 :1968–1974.
-
24
Walsh DS, Wilairatana P, Tang DB, Heppner DG Jr, Brewer TG, Krudsood S, Silachamroon U, Phumratanaprapin W, Siriyanonda D, Looareesuwan S, 2004. Randomized trial of 3-dose regimens of tafenoquine (WR238605) versus low-dose primaquine for preventing Plasmodium vivax malaria relapse. Clin Infect Dis 39 :1095–1103.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 165 | 139 | 10 |
| Full Text Views | 392 | 5 | 0 |
| PDF Downloads | 100 | 8 | 0 |
A Randomized, Double-Blind, Safety and Tolerability Study to Assess the Ophthalmic and Renal Effects of Tafenoquine 200 mg Weekly versus Placebo for 6 Months in Healthy Volunteers
Kevin J. Leary
Kevin J. Leary
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Michael A. Riel
Michael A. Riel
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Michael J. Roy
Michael J. Roy
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Louis R. Cantilena
Louis R. Cantilena
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Daoqin Bi
Daoqin Bi
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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D. Craig Brater
D. Craig Brater
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Corina van de Pol
Corina van de Pol
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Khadeeja Pruett
Khadeeja Pruett
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Caron Kerr
Caron Kerr
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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James M. Veazey Jr
James M. Veazey Jr
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Ronnie Beboso
Ronnie Beboso
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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Colin Ohrt
Colin Ohrt
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland; Uniformed Services University of the Health Sciences, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; Acufocus, Inc., Irvine, California; GlaxoSmithKline Research and Development, Greenford, Middlesex, United Kingdom; Chiltern International Ltd., Early Phase Unit, Slough, Berkshire, United Kingdom; Walter Reed Army Institute of Research, Silver Spring, Maryland
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A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m2) after 6 months of dosing, with a treatment difference of −0.061 (95% confidence interval, −0.168, 0.045), and non-inferiority margin of −0.247 mL/s/1.73 m2. Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.
Author Notes
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-
1
Mendis K, Sina BJ, Marchesini P, Carter R, 2001. The neglected burden of Plasmodium vivax malaria. Am J Trop Med Hyg 64 :97–106.
-
2
Price RN, Tjitra E, Guerra CA, Yeung S, White NJ, Anstey NM, 2007. Vivax malaria: neglected and not benign. Am J Trop Med Hyg 77 :79–87.
-
3
Baird JK, 2005. Effectiveness of antimalarial drugs. N Engl J Med 352 :1565–1577.
-
4
Crockett M, Kain KC, 2007. Tafenoquine: a promising new antimalarial agent. Expert Opin Investig Drugs 16 :705–715.
-
5
Peters W, 1999. The evolution of tafenoquine–antimalarial for a new millennium? J R Soc Med 92 :345–352.
-
6
World Health Organization, 2006. Guidelines for the Treatment of Malaria. Geneva, Switzerland, WHO. Available at: www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed September 4, 2007.
-
7
Walsh DS, Eamsila C, Sasiprapha T, Sangkharomya S, Khaewsathien P, Supakalin P, Tang DB, Jarasrumgsichol P, Cherdchu C, Edstein MD, Rieckmann KH, Brewer TG, 2004. Efficacy of monthly tafenoquine for prophylaxis of Plasmodium vivax and multidrug-resistant P. falciparum malaria. J Infect Dis 190 :1456–1463.
-
8
Walsh DS, Looareesuwan S, Wilairatana P, Heppner DG Jr, Tang DB, Brewer TG, Chokejindachai W, Viriyavejakul P, Kyle DE, Milhous WK, Schuster BG, Horton J, Braitman DJ, Brueckner RP, 1999. Randomized dose-ranging study of the safety and efficacy of WR 238605 (Tafenoquine) in the prevention of relapse of Plasmodium vivax malaria in Thailand. J Infect Dis 180 :1282–1287.
-
9
Melinda Gates Foundation, 2007. Eradication of Malaria. Available at: http://www.gatesfoundation.org/MediaCenter/Speeches/Co-ChairSpeeches/BillgSpeeches/BGSpeechMalariaForum-071017.htm. Accessed November 2007.
-
10
Nasveld P, Edstein M, Brennan L, 2008. Randomized, double-blind study of the safety, tolerability and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in non-immune subjects. Clin Infect Dis (submitted).
-
11
Barbur J, Harlow A, 1993. Colour vision testing using spatiotemporal luminance masking: psychophysical and pupillometric methods. Drum B, ed. Colour vision deficiencies XI. Proceedings of the Eleventh Symposium of the International Research Group on Colour Vision Deficiencies, Sydney, Australia, June 21–23, 1991. Dordrecht: Kluwer Academic Publishers, 417–426.
-
12
Bi D, Leary KJ, Weitz JA, Cherstniakova SA, Reil MA, Roy MJ, Cantilena LR, 2007. High performance liquid chromatographic measurement of iothalamate in human serum and urine for evaluation of glomerular filtration rate. J Chromatogr B Analyt Technol Biomed Life Sci 856 :95–99.
-
13
Dowling TC, Frye RF, Fraley DS, Matzke GR, 1999. Comparison of iothalamate clearance methods for measuring GFR. Pharmacotherapy 19 :943–950.
-
14
Gaspari F, Mosconi L, Vigano G, Perico N, Torre L, Virotta G, Bertocchi C, Remuzzi G, Ruggenenti P, 1992. Measurement of GFR with a single intravenous injection of nonradioactive iothalamate. Kidney Int 41 :1081–1084.
-
15
Clopper C, Pearson E, 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26 :404–413.
-
16
Anderson N, Borlak J, 2006. Drug-induced phospholipidosis. FEBS Lett 580 :5533–5540.
-
17
Jones SK, 1999. Ocular toxicity and hydroxychloroquine: guidelines for screening. Br J Dermatol 140 :3–7.
-
18
Lullmann H, Lullmann-Rauch R, Wassermann O, 1975. Drug-induced phospholipidoses. II. Tissue distribution of the amphiphilic drug chlorphentermine. CRC Crit Rev Toxicol 4 :185–218.
-
19
Brater DC, 2002. Measurement of renal function during drug development. Br J Clin Pharmacol 54 :87–95.
-
20
Kemperman FA, Surachno J, Krediet RT, Arisz L, 2002. Cimetidine improves prediction of the glomerular filtration rate by the Cockcroft-Gault formula in renal transplant recipients. Transplantation 73 :770–774.
-
21
Hale BR, Owusu-Agyei S, Fryauff DJ, Koram KA, Adjuik M, Oduro AR, Prescott WR, Baird JK, Nkrumah F, Ritchie TL, Franke ED, Binka FN, Horton J, Hoffman SL, 2003. A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum. Clin Infect Dis 36 :541–549.
-
22
Lell B, Faucher JF, Missinou MA, Borrmann S, Dangelmaier O, Horton J, Kremsner PG, 2000. Malaria chemoprophylaxis with tafenoquine: a randomised study. Lancet 355 :2041–2045.
-
23
Shanks GD, Oloo AJ, Aleman GM, Ohrt C, Klotz FW, Braitman D, Horton J, Brueckner R, 2001. A new primaquine analogue, tafenoquine (WR 238605), for prophylaxis against Plasmodium falciparum malaria. Clin Infect Dis 33 :1968–1974.
-
24
Walsh DS, Wilairatana P, Tang DB, Heppner DG Jr, Brewer TG, Krudsood S, Silachamroon U, Phumratanaprapin W, Siriyanonda D, Looareesuwan S, 2004. Randomized trial of 3-dose regimens of tafenoquine (WR238605) versus low-dose primaquine for preventing Plasmodium vivax malaria relapse. Clin Infect Dis 39 :1095–1103.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 165 | 139 | 10 |
| Full Text Views | 392 | 5 | 0 |
| PDF Downloads | 100 | 8 | 0 |