Post J, Williams C; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3224.
J. Post, Mcdowell HCC, 4021 N 30 th st, ste 4, Phoenix, Az 85016-6810, United States, Tel.: +1 602 344 6550, Fax: +1 602 344 6551, E-mail: jmpost@hotmail.com
Background: Nelfinavir (NFV) dosed bid has shown efficacy in patients antiretroviral (ARV) naive or protease inhibitor (PI) inexperienced. This trial examined switching NFV 750 mg tid to 1250 mg bid in NFV experienced patients on a stable ARV regimen. Methods: Patients attending a community HIV clinic were eligible if clinically stable on an ARV regiment including NLF tid for at least 3 months with a HIV-RNA >500 by bDNA. Thirty subjects were randomized 1:1 to NFV 750 mg tid or 1250 mg bid with continuation of other ARV. Viral load (VL), CD4, lipids, adherence and adverse events were followed. Ten subjects in bid arm underwent pharmacokinetic (PK) studies of NFV. Results: At 84 weeks 19 subjects were evaluable. In the tid arm VL was >50 in 9/9. In 3/9 VL was >50 >500 at baseline. In bid arm VL was >50 in 6/10. In 4/10 the VL was >1000 with 3/4 with VL >50 >500 at baseline. Cause of subject drop out was: lost to followup in 2/6 in tid arm, 3/5 in bid arm; poor adherence in 3/6 tid arm, 2/5 bid arm, 1/6 intercurrent illness in tid arm. PK showed significantly higher Cmax for bid dosing. Ctrough, 24 hour AUC, time to Cmax were similar in both dosing arms. No significant changes in lipids were noted. Both doses were well tolerated. Conclusions: ARV experienced patients with a VL >500 on a combination regimen including NLF may be safely and effectively switched to a bid regimen with a comparable dose of NLV. Poor adherence was the best predictor of regimen failure.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Clinical Trials as Topic
- HIV Infections
- Humans
- Nelfinavir
- Viral Load
- organization & administration
Other ID:
UI: 102239134
From Meeting Abstracts