A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

Summary

The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.

Timeline

Start

—

Primary completion

—

Completion

2000-05

Publications

• Background Pfister M, Labbe L, Hammer SM, Mellors J, Bennett KK, Rosenkranz S, Sheiner LB; Adult AIDS Clinical Trial Group Study 398. Population pharmacokinetics and pharmacodynamics of efavirenz, nelfinavir, and indinavir: Adult AIDS Clinical Trial Group Study 398. Antimicrob Agents Chemother. 2003 Jan;47(1):130-7. doi: 10.1128/AAC.47.1.130-137.2003.
• Background Pfister M, Labbe L, Lu JF, Hammer SM, Mellors J, Bennett KK, Rosenkranz S, Sheiner LB; AIDS Clinical Trial Group Protocol 398 Investigators. Effect of coadministration of nelfinavir, indinavir, and saquinavir on the pharmacokinetics of amprenavir. Clin Pharmacol Ther. 2002 Aug;72(2):133-41. doi: 10.1067/mcp.2002.126183.
• Background Hammer SM, Vaida F, Bennett KK, Holohan MK, Sheiner L, Eron JJ, Wheat LJ, Mitsuyasu RT, Gulick RM, Valentine FT, Aberg JA, Rogers MD, Karol CN, Saah AJ, Lewis RH, Bessen LJ, Brosgart C, DeGruttola V, Mellors JW; AIDS Clinical Trials Group 398 Study Team. Dual vs single protease inhibitor therapy following antiretroviral treatment failure: a randomized trial. JAMA. 2002 Jul 10;288(2):169-80. doi: 10.1001/jama.288.2.169.
• Results Sun J, Nagaraj HN, Reynolds NR. Discrete stochastic models for compliance analysis based on an AIDS Clinical Trial Group (ACTG) study. Biom J. 2007 Aug;49(5):731-41. doi: 10.1002/bimj.200610368.
• Results Ghosh P, Ghosh K, Tiwari RC. Joint modeling of longitudinal data and informative dropout time in the presence of multiple changepoints. Stat Med. 2011 Mar 15;30(6):611-26. doi: 10.1002/sim.4119. Epub 2010 Nov 30.

Drugs

Indications