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A phase 1 study to evaluate the effect of dolutegravir on renal function via measurement of iohexol and para‐aminohippurate clearance in healthy subjects
Open accessAbstract
Aim: Dolutegravir (DTG; S/GSK 1349572) is under clinical development as a once daily, unboosted integrase inhibitor for the treatment of HIV infection. The effect of DTG on glomerular filtration rate (GFR), effective renal plasma flow (ERPF), and creatinine clearance (CL cr) was evaluated in 34 healthy volunteers. Methods: Subjects received DTG 50 mg (once daily or twice daily) or placebo for 14 days. GFR was measured by iohexol plasma clearance, ERPF was assessed by para‐aminohippurate plasma clearance and CL cr was measured by 24 h urine collection. Results: All treatments were generally well tolerated. A modest decrease (10–14%) in CL cr was observed, consistent with clinical study observations. DTG 50 mg once daily and twice daily had no significant effect on GFR or ERPF compared with placebo over 14 days in healthy subjects. Conclusions: These findings support in vitro data that DTG increases serum creatinine by the benign inhibition of the organic cation transporter 2, which is responsible for tubular secretion of creatinine.
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Cited by
Clotet, B., Feinberg, J., van Lunzen, J., Khuong-Josses, M.-A., Antinori, A., Dumitru, I., Pokrovskiy, V., Fehr, J., Ortiz, R., Saag, M., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(14)60084-2 · Cited by 507
Creatinine: from physiology to clinical application
Kashani, K., Rosner, M. H., & Ostermann, M. (2020) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2019.10.025 · Cited by 474
Raffi, F., Jaeger, H., Quiros-Roldan, E., Albrecht, H., Belonosova, E., Gatell, J. M., Baril, J.-G., Domingo, P., Brennan, C., Almond, S., et al. (2013) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(13)70257-3 · Cited by 379
Tsiang, M., Jones, G. S., Goldsmith, J., Mulato, A., Hansen, D., Kan, E., Tsai, L., Bam, R. A., Stepan, G., Stray, K. M., et al. (2016) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.01474-16 · Cited by 290
Metadata
- Authors
- Koteff, J., Borland, J., Chen, S., Song, I., Peppercorn, A., Koshiba, T., Cannon, C., Muster, H., & Piscitelli, S. C.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2013-03-15
- Volume
- 75
- Issue
- 4
- Pages
- 990-996
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- OpenAlex
- W1549276187
- Cited by
- 196
- References
- 0
- FWCI
- 10.72
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Koteff, J., Borland, J., Chen, S., Song, I., Peppercorn, A., Koshiba, T., Cannon, C., Muster, H., & Piscitelli, S. C. (2013). 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. https://doi.org/10.1111/j.1365-2125.2012.04440.x
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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