Sension M, Elion R, Green L, Lindquist C, Richardson W, Becker M; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1998 Sep 24-27; 38: 434 (abstract no. I-218).
North Broward Hospital District, Fort Lauderdale, FL.
Three pilot studies assessed the antiviral activity, durability of response and tolerability of bid VIRACEPT combined with stavudine (d4T) or zidovudine (AZT) and lamivudine (3TC) for 48 weeks in treatment-naive HIV-infected patients. Eligible patients included individuals with HIV-RNA > 15,000 copies/mL and CD4 cell count > 100 cells/mm3 at screening. All patients received VIRACEPT 1,250 mg two times daily (bid) + d4T 40 mg bid or AZT 200mg tid + 3TC 150 mg bid. At screening 36 antiretroviral naive patients had HIV RNA >15,000 copies/mL by PCR (median log10 = 4.88, mean log10 = 4.90 copies/mL) and CD4 cell counts >100 cells/mm3 (mean = 346 cells/mm3). Thirty-four patients took NFV 1250 mg bid + d4T/3TC or AZT/3TC. Based on results from a European multicenter trial, NFV 1000 mg bid taken by 10 patients was increased to 1250mg bid, at week 24, for the remainder of the study. Preliminary results include 19 of 20 evaluable patients at 36 weeks (one patient was lost to follow up). The mean HIV-RNA at baseline was 162,537. At 36 weeks, 19 of 20 had HIV RNA below the level of detection (PCR < 400) and 13 of 19 patients had HIV-RNA below the level of detection (PCT < 50). The mean baseline CD4 cell count was 340. No serious adverse events were reported. Four patients reported transient, moderate diarrhea and three patients reported nausea. All patients complied with their drug regimen and tolerated the adverse events. Each patient will continue in the study for 48 weeks. Based on the preliminary analysis, all patients taking Viracept administered as a 1,250mg bid regimen combined with d4T 40mg BID + 3TC 150mg bid achieved viral load measurements below detectable limits (400 copies/ml) at 12 weeks and 13 of 20 had HIV RNA below the level of detection (PCR < 50) after 36 weeks of therapy with no significant adverse effects.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Drug Therapy, Combination
- HIV
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Lamivudine
- Nelfinavir
- Safety
- Stavudine
- Zidovudine
- drug therapy
- therapy
Other ID:
UI: 102188375
From Meeting Abstracts