Salgo MP, Beattie D, Bragman K, Donatacci L, Jones M, Montgomery L; International Conference on AIDS.

Int Conf AIDS. 1996 Jul 7-12; 11: 24 (abstract no. Mo.B.410).

Hoffmann-La Roche, Nutley, NJ. Fax: (201) 812-3629.

Objective: The objective of this randomized, double-blind, phase II/III, multicenter study was to compare the safety, tolerability and efficacy of SQV and ddC, alone and in combination, based on clinical endpoints and laboratory markers of immunological and virologic activity. Methods: A total of 978 HIV-infected patients with a screening CD4 lymphocyte count of 50-300 cells/mm3, and a minimum of 16 weeks of prior ZDV therapy, were randomized to receive ddC 0.75 mg q8h, SQV 600 mg q8h, or SQV 600 mg + ddC 0.75 mg q8h. Laboratory marker data (CD4 lymphocyte response and changes in viral load as HIV-1 RNA) from a planned interim analysis of surrogate marker activity from 451 evaluable patients who had received a minimum of 16 weeks treatment, or who had dropped out before 16 weeks, are presented. Results: Patients randomized to the SQV + ddC group had a higher and more sustained increase in CD4 lymphocyte counts, as measured by the DAVG16, compared with patients in the ddC group (p is less than 0.001) and in the SQV group (p=0.001). The difference between SQV and ddC was not significant (p=0.12). The median DAVG values were 26 cells/mm3 for the SQV + ddC group, 10 cells/mm3 for the SQV group, and 3 cells/mm3 for the ddC group. Similarly, combination therapy produced a greater and more sustained decrease in viral load than either monotherapy (p is less than 0.001). There was a statistically significant difference in viral load, favoring ddC, between the SQV and ddC groups (p=0.001). The median DAVG16 values were -0.6 log10 copies/mL for the SQV + ddC group, -0.1 log10 copies/mL for the SQV group, and -0.3 log10 copies/mL for the ddC group. SQV was well tolerated alone and in combination with ddC. Conclusions: The combination of SQV + ddC was associated with greater increases in CD4 lymphocyte count and greater suppression of viral load, as measured by HIV-1 RNA, than either SQV or ddC monotherapy.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Anti-HIV Agents
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• CD4-Positive T-Lymphocytes
• Drug Therapy, Combination
• HIV
• HIV Core Protein p24
• HIV Infections
• HIV Protease
• HIV Protease Inhibitors
• HIV Seropositivity
• Humans
• Saquinavir
• Viral Load
• Zalcitabine
• Zidovudine
• drug therapy
• immunology
• therapy

Other ID:

• 96920925

UI: 102216824

From Meeting Abstracts