Robertson M, Nessly M, Aversa D, Leavitt R; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 189 (abstract no. 648).
Merck Research Labs, West Point, PA.
Background. Use of protease inhibitors may lead to changes in lipid metabolism, but this has not been studied in randomized clinical trials. Objectives. To analyze changes in serum cholesterol (SC) and triglyceride levels (TG) in patients enrolled in Phase II trials of CRIXIVAN(r). Methods. Retrospective analysis of SC and TG in ART naive patients randomized to treatment with IDV (as monotherapy or combined with NRTIs) or with NRTIs only for 24 weeks followed by open label combination therapy to 48 weeks. Baseline SC and TG were compared to levels at weeks 24 and 48. Results. Baseline SC and TG were similar in both groups. SC increased from a median of 157 mg/dl at baseline to 177 mg/dl at week 24 in patients randomized to IDV (n=80) but did not change in the NRTIs group (160 mg/dl at baseline vs. 157 at week 24, n=32) (p<0.0001, Wilcoxon rank sum test). After the addition of IDV at week 24, SC increased in the NRTI group to 178 mg/dl at week 48. SC did not increase further at week 48 among patients initially receiving IDV. Very few patients (<5% on IDV, none on NRTIs) developed elevated SC (>240 mg/dl), and the majority of patients on either IDV (72%) or NRTIs (97%) maintained ideal SC levels (<200 mg/dl). Week 24 differences in SC were still significantly different between the groups even when adjusted for baseline cholesterol, viral load, CD4 counts, and BMI or changes in viral load and CD4 count. TG did not significantly change in either group throughout the study. Conclusions. Treatment with IDV increased serum cholesterol, but the observed increases would rarely require pharmacological intervention.
Publication Types:
Keywords:
- CD4 Lymphocyte Count
- Humans
- Indinavir
- Triglycerides
- Viral Load
- organization & administration
Other ID:
UI: 102195413
From Meeting Abstracts