78
Views
6
CrossRef citations to date
0
Altmetric
Original Articles

Tutorial Reduces Protocol Deviations in Multicenter ACTG Trials with Pharmacology Endpoints

, , &
Pages 203-209 | Published online: 14 Jan 2015

REFERENCES

  • DiFrancesco R, Holland DT, Schiffhauer JE, Robbins BL, Tooley KM, Morse GD. A quality assurance program for AIDS clinical trials group pharmacology studies. Qua! Assur J. 2005;9:23–30.
  • StatXact 7 PROCs for SAS Users. A software package for exact nonparametric inference. Cambridge, MA: Cytel Inc; 2005.
  • Blyth CR, Still HA. Binomial confidence intervals. J Am Stat Assoc. 1983;78:108–116.
  • Fletcher CV, Acosta EP, Cheng H, et al., for the ACTG 884 Protocol Team. Competing drug-drug interactions among multidrug antiretroviral regimens used in the treatment of HIV-infected subjects: ACTG 884. AIDS. 2000;14(16): 2495–2501.
  • Fletcher CV, Jiang H, Brundage RC, et al. Sex-based dif-ferences in saquinavir pharmacology and virologic re-sponse in AIDS Clinical Trials Group Study 359. J Infect Dis. 2004;189:1176–1184.
  • DiCenzo R, Forrest A, Squires KE, et al., and the Adult AIDS Clinical Trials Group Protocol 368/886 Study Team. Indinavir, efavirenz, and abacavir pharmacokinetics in hu-man immunodeficiency virus-infected subjects. Antimicrob Agents Chemother. 2003;47(6):1929–1935.
  • Haas DW, Ribaudo HJ, Kim RB, et al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS. 2004;18(18):2391–2400.
  • Ribaudo HJ, Haas DW, Tierney C, et al. Pharmacogenetics of plasma efavirenz exposure after treatment discontinua-tion: an adult AIDS Clinical Trials Group Study. Clin Infect Dis. 2006;42:401–407.
  • Jian-Feng L, Blaschke TF, Flexner C, Rosenkranz SL, Sheiner LB. Model-based analysis of the pharmacokinetic interactions between ritonavir, nelfinavir, and saquinavir after simultaneous and staggered oral administration. Drug Metabol Disposition. 2002:30;1455–1461.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.