Hathaway B, Joseph Wheat L; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3228.
B. Hathaway, ECU School of Medicine, Section of Infectious Diseases 3E-117, Brody Building, Greenville, NC 27858, United States, Tel.: +1 252 816 32 56, Fax: +1 252 816 34 72, E-mail: bhathaway@brody.med.ecu.edu
Background: An analysis of changes in lipid metabolism associated with BID or TID regimens of the potent protease inhibitor (PI), Fortovase (FTV), was performed. Lipid and glucose levels collected during study NR15520, comparing the antiretroviral (ARV) activity and safety of FTV BID and TID regimens, were assessed and compared. Methods: A 48-week analysis of non-fasting serum cholesterol (CHOL), triglyceride (TG) and glucose (GLU) levels from 840 ARV naive or nucleoside analogue (NA) experienced patients was performed. Treatments were FTV 1200mg TID+2NAs (Arm A, n = 281), FTV 1600mg BID+2NAs (Arm B, n = 279), or FTV 1200mg BID+NFV 1250mg BID+1NA (Arm C, n = 280). In arms A, B and C, respectively, 75%, 77% and 73% were naive. In arms A and B, respectively, 71% and 67% of naive and 38% and 43% of experienced received 3TC/d4T; most others received AZT/3TC or d4T/ddI. In arm C, 90% of naive and 71% of experienced received d4T. Results: Significant differences (p>0.05) between baseline (BL) and Week 48 (W48) were identified using least squares means analyses. Results are shown for arms A, B and C, respectively. Mean BL CHOL = 165, 166, 168 mg/dL; significant mean increases at W48 = 21, 14, 38 mg/dL; mean % change at W48 = 15%, 11%, 24%. Mean BL TG = 182, 177, 181mg/dL; significant mean increases at W48 = 31, 24, 53 mg/dL; mean % change at W48 = 30%, 20%, 37%. 13 patients fasting at BL and W24 showed mean changes in TG of -1.0(n = 4), -46(n = 5), +43(n = 4) mg/dL. Mean BL GLU = 95, 94, 93 mg/dL. Significant mean increase at W48 was observed in arm A only (5mg/dL). Mean % change was small (6%, 3%, 4%) in all arms. Conclusions: Glucose levels appeared relatively unaltered. The dual PI regimen appeared to affect lipid markers slightly more than the single PI regimens, although changes in serum lipids were not apparent in the small cohort of fasting patients. A ranking for the regimens studied based on their effects on serum lipids is FTV BID > FTV TID > FTV BID+ NFV BID.
Publication Types:
Keywords:
- Adult
- Carrier Proteins
- Didanosine
- Humans
- Lamivudine
- Receptors, Cytoplasmic and Nuclear
- Saquinavir
- Stavudine
- Zidovudine
- soluble guanylyl cyclase
Other ID:
UI: 102239138
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