Lalezari J, Siemon-Hryczyk P, Feinberg J, Sension M, Macko J, Seput-Dingle F, Duff F; International Conference on AIDS.

Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3229.

J. Lalezari, Quest Clinical Research, 2300 Sutter Street, San Francisco, CA 94115, United States, Tel.: +1 415 353 08 00, Fax: +1 415 353 08 01

Background: Fortovase(tm) (Saquinavir Soft Gel Capsules, FTV) is shown to be a potent protease inhibitor (PI) in combination regimens. The objective of this study is to compare the antiviral activity and safety of FTV given twice daily (BID), either as the sole PI plus 2 nucleoside analogues (NAs), or in a dual PI regimen with nelfinavir (NFV) plus 1 NA, to FTV given three times daily (TID) plus 2 NAs. Methods: 840 antiretroviral naive or NA experienced patients with HIV-RNA > = 5000 c/mL were randomized to receive FTV 1200mg TID (Arm A, n = 281) or FTV 1600mg BID (Arm B, n = 279), each in combination with 2 new NAs of choice, or FTV 1200mg BID + NFV 1250mg BID (Arm C, n = 280) + 1 new NA of choice. The study duration is > = 48 weeks. Results: For arms A (FTV TID + 2 NAs), B (FTV BID + 2 NAs), and C (FTV BID + NFV BID + 1 NA), respectively, baseline data are: mean viral load (log10 c/mL) = 4.8, 4.7 and 4.8; mean CD4 cell count/uL = 307, 322 and 312. Week 48 results are: proportion of patients with HIV-RNA below level of quantification (BLQ) of the Amplicor assay (400 c/mL) by on-treatment (OT) analysis = 79%, 79% and 80% (arms A-C, respectively). Mean increase in CD4 cell count/uL = +212, +187, +225, respectively. Intent-to-treat (ITT) analysis at 48 weeks: HIV-RNA BLQ 400 c/mL = 43%, 41% and 41%, respectively. All regimens were generally well tolerated and marked laboratory abnormalities were rare. The most frequently reported adverse events related to study drug in all arms were gastrointestinal. Conclusion: Fortovase(tm) TID and BID regimens were found to be comparable in efficacy as measured by HIV-RNA suppression and CD4 cell count increase. Additionally, Fortovase(tm) TID and BID regimens were well tolerated, with infrequent laboratory abnormalities and an excellent safety profile.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Biomedical Research
• CD4 Lymphocyte Count
• Clinical Protocols
• HIV Infections
• HIV Seropositivity
• HIV-1
• Humans
• Nelfinavir
• Saquinavir
• Viral Load

Other ID:

• GWAIDS0001648

UI: 102239139

From Meeting Abstracts