Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir

Summary

In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes. IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.

Timeline

Start

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Primary completion

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Completion

2006-08

Publications

• Results Acosta EP, Wu H, Hammer SM, Yu S, Kuritzkes DR, Walawander A, Eron JJ, Fichtenbaum CJ, Pettinelli C, Neath D, Ferguson E, Saah AJ, Gerber JG; Adult AIDS Clinical Trials Group 5055 Protocol Team. Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals. J Acquir Immune Defic Syndr. 2004 Nov 1;37(3):1358-66. doi: 10.1097/00126334-200411010-00004.
• Results King JR, Gerber JG, Fletcher CV, Bushman L, Acosta EP. Indinavir protein-free concentrations when used in indinavir/ritonavir combination therapy. AIDS. 2005 Jul 1;19(10):1059-63. doi: 10.1097/01.aids.0000174452.78497.54.
• Results Wu H, Huang Y, Acosta EP, Park JG, Yu S, Rosenkranz SL, Kuritzkes DR, Eron JJ, Perelson AS, Gerber JG. Pharmacodynamics of antiretroviral agents in HIV-1 infected patients: using viral dynamic models that incorporate drug susceptibility and adherence. J Pharmacokinet Pharmacodyn. 2006 Aug;33(4):399-419. doi: 10.1007/s10928-006-9006-4. Epub 2006 Apr 1.

Drugs

Indications