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9th Conference on Retroviruses and Opportunistic InfectionsSeattle, Washington - February 24 -February 28, 2002 |
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Conf Retroviruses Opportunistic Infect 2002 Feb 24-28;9:abstract no. 33
P. Kumar*1, A. Rodriguez-French 2, M. Thompson3, K. Tashima4, V. Williams5, P. Wannamaker
5, and M. Shaefer5
1Georgetown Univ. Med. Ctr., Washington, DC; 2San Fernando Hosp., Panama City, Panama; 3AIDS Res. Consortium, Atlanta, GA; 4The Miriam Hosp., Providence, RI; and 5GlaxoSmithKline, Res. Triangle Park, NC
BACKGROUND: Hyperlipidemia is a common side effect of HAART therapy. The effect that non-PI-containing regimens have on the development of hyperlipidemia and fat redistribution (FR) is not fully known. Our objectives were to evaluate changes in fasting metabolic parameters, clinical evaluations of FR, safety, and efficacy in subjects treated with COM/ABC vs COM/NFV vs d4T/3TC/NFV for 96 weeks.
METHODS: 258 non-diabetic, ART-naïve subjects with CD4 >50 cells/mm3 were randomized 1:1:1. Evaluations consisted of fasting lipid profiles and other clinical evaluations of FR at baseline through 96 weeks. Results were compared in an analysis of covariance model adjusting for baseline.
RESULTS: A planned interim analysis at 48 weeks (50% female, 40% African American, 37% Hispanic) indicate significant increases in LDL and total cholesterol in both of the PI-containing arms compared to the COM/ABC arm.
| LS Mean (SE) | COM/ABC N=86 |
COM/NFV N=89 |
D4T/3TC/NFV N=83 |
| Baseline LDL (mg/dL) | 91.5 (3.6) | 95.2 (3.4) | 95.3 (3.6) |
| LDL- Δ from BL†‡ | -2.4 (4.2) n=55 |
19.4 (4.1) n=55 |
27.1 (4.5) n=49 |
| BL Cholesterol | 154.7 (3.9) | 164.3 (3.8) | 160.4 (4.0) |
| Cholesterol- Δ from BL†‡ | 9.9 (4.7) n=57 |
32.1 (4.6) n=57 |
45.7 (4.9) n=54 |
| BL Triglycerides | 128.6 (10.1) | 148.4 (9.8) | 142.2 (10.4) |
| Triglycerides- Δ from BL‡ | 23.6 (13.2) n=57 |
31.4 (13.1) n=57 |
69.3 (13.8) n=54 |
| BL Lactate | 9.7 (0.7) | 10.2 (0.6) | 10.9 (0.7) |
| Lactate- Δ from BL‡ | (1.2) n=58 |
2.3 (1.2) n=55 |
7.9 (1.3) n=51 |
| BL HIV-1 RNA (log10) Adj. Mean (SE) | 4.67 (0.06) | 4.74 (0.06) | 4.77 (0.06) |
| Subjects with <50 copies HIV-1 RNA at 48-weeks (ITT M=F) n/N (%) |
41/86 (48) | 42/89 (47) | 32/83 (39) |
| BL CD4+ cell count | 309 (22.9) | 320 (21.9) | 315 (23.2) |
| CD4+ ? from BL 48-weeks | 160 (19.4) n=56 |
140 (19.0) n=56 |
159 (20.2) n=54 |
| † COM/ABC vs COM/NFV yielded p<0.05 ‡COM/ABC vs d4T/3TC/NFV yielded p<0.05 Suspected hypersensitivity reaction to abacavir occurred in 2% of subjects. |
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CONCLUSIONS: These 48-week results indicate that therapy with COM/ABC has comparable virologic and immunologic efficacy with a more favorable lipid profile as compared to PI-containing regimens. Gender differences will be presented.
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Copyright © 2002 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.
