Lohmeyer J, Selhorst J, Friese G, Teichmann J, Discher T; International Conference on AIDS.

Int Conf AIDS. 1998; 12: 73 (abstract no. 12303).

Department of Internal Medicine, JLU, Giessen, Germany.

OBJECTIVES: To evaluate on the basis of intention to treat the immunological and anti-retroviral efficacy, pharmacokinetics, safety and tolerance of a four drug BID regimen combining nelfinavir/saquinavir double protease inhibitor (PI) treatment with two nucleoside reverse transcriptase inhibitors (NRTI) as salvage therapy in heavily pretreated patients with advanced HIV-disease. DESIGN: 25 HIV-infected patients with CD4 cells < 300/microL who had previously been treated with 2 NRTI/PI combination therapy and had failed or were intolerant to such treatment were enrolled in an exploratory, single arm, open-label study with nelfinavir 1250 mg BID+ saquinavir 1000 mg BID in combination with 2 NRTI's. METHODS: Patients were were assessed monthly for CD4 cell count and plasma HIV-RNA (NASBA; detection limit 40 copies/mL). In addition, plasma concentrations of protease inhibitors were quantified in heparinized blood samples obtained before intake and at 1, 2, 3, 4, 8, 12 hr intervals using validated high-performance HPLC. RESULTS: Nineteen of 25 patients have completed 24 weeks of treatment. Baseline median and mean HIV RNA levels were 4.3 and 4.5 log10 copies/mL respectively (range 3.9-6.6). CD4 cell counts at baseline ranged from 1 to 295 cells/microL with median and mean values of 80 and 118 CD4 cells/microL respectively. Mean decrease in HIV RNA levels was 1.8 log10 at 8 weeks and 1.6 log10 at 24 weeks. Mean increase in CD4 cells was 118 (week 8) and 140 cells/microL (week 24). The proportion of patients with plasma RNA levels below 500 and 40 copies, respectively, were 60% and 47% at week 8 and 45% and 35% at week 24. The treatment regimen has been generally well tolerated. No treatment related grade 3 or 4 adverse effects or clinical significant laboratory abnormalities were seen. Two of 25 patients withdrew due to non-tolerated diarrhea. CONCLUSION: Nelfinavir-saquinavir combination treatment in a four drug BID schedule with 2 NRTI's is effective as rescue therapy in late HIV-infection in terms of prompt and sustained HIV plasma RNA level reduction and CD4 cell count increase.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Anti-HIV Agents
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Clinical Protocols
• Drug Therapy, Combination
• HIV
• HIV Infections
• HIV Protease
• HIV Protease Inhibitors
• HIV Seropositivity
• Humans
• Nelfinavir
• Protease Inhibitors
• Reverse Transcriptase Inhibitors
• Salvage Therapy
• Saquinavir
• drug therapy
• therapy

Other ID:

• 98387078

UI: 102227331

From Meeting Abstracts