Journal article
Safety, tolerability, and antiretroviral effects of ritonavir-nelfinavir combination therapy administered for 48 weeks
Journal of acquired immune deficiency syndromes (1999), Vol.25(4), pp.322-328
2000
DOI: 10.1097/00042560-200012010-00005
PMID: 11114832
Abstract
Objective:To evaluate the safety, tolerability, and anti-HIV activity of ritonavirnelfinavir (RTV-NFV).
Design:Single-site, open-label, nonrandomized, multiple-dose trial of RTV combined with two doses of NFV in protease inhibitor (PI)-naive, HIV-infected patients.
Methods:Mean baseline HIV RNA was 39,500 copies/ml; mean baseline CD4 count was 323 cells/mm3. All patients received RTV at a dosage of 400 mg twice daily. Cohorts I (N = 10) and II (N = 10) received NFV at a dosage of 500 mg and 750 mg twice daily, respectively, for the initial 12 weeks of the study before allowing intensification with reverse transcriptase inhibitors.
Results:The commonest effects of RTV-NFV therapy were study drug-related moderate-to-severe diarrhea (9 patients in cohorts I and II) and drug-related moderateto-severe nausea (4 patients in cohorts I and II). HIV RNA was suppressed in a biphasic manner. At 48 weeks in cohort I, mean HIV RNA reduction was 2.82 log10 copies/ml (standard error [SE] = .61; p = .001; N = 4); mean CD4 cell count increase was 236 cells/mm3 (SE = 67.1; p = .006; N = 4). In cohort II, mean HIV RNA reduction at Week 48 was 2.21 log10 copies/ml (SE = .430; p = .001; N = 8); mean CD4 cell count increase was 120 cells/mm3 (SE = 47.5; p = .03; n = 8). In cohort I patients, 2 of 4 completing Week 48 had HIV RNA <20 copies/ml; and 3 of 4 had HIV RNA <400 copies/ml. In cohort II, 2 of 8 patients completing Week 48 had HIV RNA <20 copies/ml and 4 of 8 had HIV RNA <400 copies/ml. In addition, 3 patients in cohort I withdrew because of virologic failure not thought to be related to poor compliance. Moreover, 15 patients elected to add new reverse-transcriptase inhibitors (RTIs) after week 12.
Conclusions:RTV-NFV with concomitant reverse transcriptase inhibitors is a potential dual-PI option for Pi-naive patients.
Details
- Title: Subtitle
- Safety, tolerability, and antiretroviral effects of ritonavir-nelfinavir combination therapy administered for 48 weeks
- Creators
- Charles P RAINES - Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesCharles FLEXNER - Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesJoel E GALLANT - Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesEugene SUN - Abbott Laboratories, Abbott Park, Illinois, United StatesMargo HEATH-CHIOZZI - Abbott Laboratories, Abbott Park, Illinois, United StatesRonald H LEWIS - Agouron Pharmaceuticals, Inc., La Jolla, California, United StatesCathy FIELDS - Abbott Laboratories, Abbott Park, Illinois, United StatesCarl DEETZ - Abbott Laboratories, Abbott Park, Illinois, United StatesLinda APUZZO - Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesSusan H ESHLEMAN - Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesJ. Brooks JACKSON - Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
- Resource Type
- Journal article
- Publication Details
- Journal of acquired immune deficiency syndromes (1999), Vol.25(4), pp.322-328
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- DOI
- 10.1097/00042560-200012010-00005
- PMID
- 11114832
- ISSN
- 1525-4135
- eISSN
- 1944-7884
- Language
- English
- Date published
- 2000
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047650202771
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