Body Composition and Metabolic Changes in Treatment-naive HIV Patients Randomized to Didanosine and Stavudine vs. Abacavir and Lamivudine                                       

Comparisons of body composition and metabolic changes among antiretroviral-naive patients randomly assigned to didanosine (Videx) and stavudine (Zerit)-- (ddI + d4T) vs. abacavir (Ziagen) and lamivudine (Epivir)- (ABC + 3TC) containing regimens were assessed in a nested substudy of an ongoing multicenter randomized trial.

At baseline and every 4 months, body cell mass and total body fat were calculated, anthropometric measurements were performed, and fasting metabolic parameters were obtained.

The rates of change (unit/mo) estimated using the slopes of regression lines and overall mean changes from baseline were compared by study assignment. Among 96 patients enrolled, 46 received ddI + d4T- and 50 received ABC + 3TC-containing regimens with a median follow-up of 32.4 months.

For both study arms, an overall increase in the rates of change was seen for body cell mass. For ddI + d4T, after an initial increase, the rates of change declined for regional fat and total body fat compared with an increase for ABC + 3TC, with the 2 arms being significantly different (P < 0.05).

For high-density lipoprotein cholesterol rates of change, ddI + d4T decreased, while ABC + 3TC increased. For both arms, low-density lipoprotein cholesterol decreased, while triglycerides increased.

Early and sustained increases in insulin and insulin resistance were seen only for ddI + d4T. In this prospective study, metabolic and body composition changes varied according to whether subjects received ddI + d4T or ABC + 3TC.

02/09/05

Reference
J C Shlay and others (for the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Body Composition and Metabolic Changes in Antiretroviral-Naive Patients Randomized to Didanosine and Stavudine vs. Abacavir and Lamivudine. Journal of Acquired Immune Deficiency Syndromes 38(2): 147-155. February 1, 2005.

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