drugset / Trial / NCT00326716
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.
Timeline
- Start
- 2006-06
- Primary completion
- 2009-01
- Completion
- 2009-08
Publications
- Xu XS, Rose A, Demers R, Eley T, Ryan J, Stouffer B, Cojocaru L, Arnold M. Quantitative determination of free/bound atazanavir via high-throughput equilibrium dialysis and LC-MS/MS, and the application in ex vivo samples. Bioanalysis. 2014;6(23):3169-82. doi: 10.4155/bio.14.251.
- Eley T, Huang SP, Conradie F, Zorrilla CD, Josipovic D, Botes M, Osiyemi O, Hardy H, Bertz R, McGrath D. Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy. AIDS Res Hum Retroviruses. 2013 Oct;29(10):1287-92. doi: 10.1089/AID.2013.0002. Epub 2013 Jul 19.
- Conradie F, Zorrilla C, Josipovic D, Botes M, Osiyemi O, Vandeloise E, Eley T, Child M, Bertz R, Hu W, Wirtz V, McGrath D. Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women. HIV Med. 2011 Oct;12(9):570-9. doi: 10.1111/j.1468-1293.2011.00927.x. Epub 2011 May 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 300 mg | Oral |
| Subject | Atazanavir | Other / unclassified | 400 mg | Oral |
| Background | Lamivudine | Other / unclassified | 150 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | Zidovudine | Small molecule | 300 mg | Oral |