Torres R, Barr MR, Weber PF, Siemon-Hryczyk M, Salgo MP, Yucaitis J, Lam WS, Busa MS; International Conference on AIDS.

Int Conf AIDS. 1996 Jul 7-12; 11: 78 (abstract no. Mo.B.1139).

AIDS Center, St. Vincent's Hospital and Medical Center, New York, NY. Fax: (212) 353-3056. E-mail: gabrieltop@AOL.com.

Objective: To study the effects of saquinavir on plasma HIV-1 RNA viral load using quantitative polymerase chain reaction (PCR) assays and to correlate the effect of these changes with clinical outcome and survival in HIV-1 infected patients with CD4 cell counts less than or equal to 300 cells/mm3 who have previously been treated with standard of care and have failed or are intolerant to such treatment. Methods: A subset of 404 patients who enrolled in the Invirase open label compassionate treatment program were enrolled in this substudy by 15 physicians from the top enrolling sites. Participation in the substudy was limited to patients who had a baseline HIV-RNA sample prior to starting therapy with saquinavir (600 mg orally three times daily). The study population was stratified into two groups: those with CD4 cell counts less than or equal to 50 cells/mm3 and those with counts 51-300 cells/mm3. Study participants are being followed for up to six months, with HIV-1 RNA PCR viral load and clinical assessments conducted at weeks 2, 4, 8, 12, 16 and 24. Results: Of the active patients participating in this virologic substudy for whom data were available, 82% of the study population was white; 98% male; 99% reported prior use of antiretroviral therapies (AZT (91%), 3TC (78%), d4T (49%), ddC (41%), ddI (41%), other protease inhibitors (1%)); and 47% reported a previous opportunistic infection. Fewer than 1% of the participants were antiretroviral naive. Median baseline CD4 cell counts and plasma HIV RNA copy number for study participants stratified by entry CD4 cell counts (less than or equal to 50 cells/mm3 and greater than 50 cells/mm3) were 15 cells with 86,240 copies and 192 cells with 19,400 copies, respectively. Conclusion: Participants in this compassionate treatment program for saquinavir had advanced HIV disease, extensive prior treatment with a variety of antiretroviral therapies, low CD4 cell counts and moderately high viral load. Analyses of the effect on plasma HIV RNA of adding saquinavir to existing nucleoside analogue regimens and the correlation with CD4 cell counts and clinical outcome will be presented.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Anti-HIV Agents
• CD4 Lymphocyte Count
• Didanosine
• Drug Therapy, Combination
• HIV
• HIV Infections
• HIV Protease
• HIV Protease Inhibitors
• HIV Seropositivity
• HIV-1
• Humans
• Lamivudine
• Male
• Plasma
• Saquinavir
• Stavudine
• Viral Load
• Zalcitabine
• Zidovudine
• drug therapy
• therapy

Other ID:

• 96921205

UI: 102217104

From Meeting Abstracts