AEGiS-15IAC: Body composition and metabolic changes in antiretroviral-naïve HIV-infected patients randomized to didanosine and stavudine (ddI+d4T) vs. abacavir and lamivudine (ABC+3TC).

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Body composition and metabolic changes in antiretroviral-naïve HIV-infected patients randomized to didanosine and stavudine (ddI+d4T) vs. abacavir and lamivudine (ABC+3TC).

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrB1360)

Shlay JC, Visnegarwala F, Bartsch G, Wang J, Peng G, El-Sadr W, Gibert C, Kotler D, Grunfeld C, Raghavan S
Denver Community Programs for Clinical Research on AIDS (CPCRA), University of Colorado Health Sciences Center, Denver, CO, United States

BACKGROUND: No randomized controlled trials have prospectively compared body composition and metabolic changes in thymidine analogue-sparing regimens vs. thymidine-analogue containing regimens.

METHODS: In a nested substudy of an ongoing multi-center randomized controlled trial of patients initiating antiretroviral therapy, we compared changes in body composition and metabolic parameters among patients randomized to ddI+d4T vs ABC+3TC. We assessed at baseline and at 4-month intervals body cell mass (BCM) and total body fat (TBF) calculated by bioelectric impedance analysis, anthropometric measurements, and fasting metabolic parameters (total cholesterol (TC), triglycerides (TG), LDL-C, HDL-C, glucose, insulin). Fat areas in midarm, midthigh and waist were calculated. The rates of change (unit/month) estimated using the slopes of regression lines and overall mean changes from baseline were compared by study assignment.

RESULTS: Among 96 patients enrolled in the substudy, 46 received ddI+d4T and 50 received ABC+3TC with 33 months follow-up and 70% in both arms initially received a protease inhibitor. The rates of change (unit/month) for body composition and metabolic parameters beyond the first follow-up visit were: [table: see text] Early and sustained mean increases in insulin were seen for ddI+d4T compared to ABC+3TC (mean change at one month: 5.9mu/ml vs. -0.3mu/ml, p=0.04)(overall mean change: 5.2mu/ml vs. 0.3mu/ml, p=0.05), but mean fasting glucose levels were not significantly different (overall mean change: 6.1mg/dL vs. 3.3mg/dL, p=0.29).

CONCLUSIONS: In this prospective trial, rates of loss of total and regional fat were significantly greater with ddI+d4T. The demonstrated differential effect on lipid metabolism and insulin by treatment assignment necessitates close clinical monitoring and ongoing longitudinal assessment of the effects of our treatment strategies.

Keywords: AEGIS, Stavudine, Didanosine, Lamivudine, Dideoxynucleosides, HIV, Acquired Immunodeficiency Syndrome, HIV Seropositivity, Anti-HIV Agents, HIV Infections, Body Composition, Thymidine, HIV Protease Inhibitors, HIV-Associated Lipodystrophy Syndrome, abacavir, Humans

040711
ThOrB1360