Changes in body shape and laboratory parameters -- including virologic and immunologic -- were assessed in 106 patients with lipodystrophy who had received a protease inhibitor (PI) for at least 9 months. Fifty-two patients were randomized to d4T + ddI + nevirapine (NVP), while 54 remained on PI therapy. CD4+ cell count and CD4% continued to increase in both groups at 24 weeks, although 2 patients in each arm showed viral rebound. There were no significant improvements in dual energy x-ray absorptiometry scans or anthropometric measurements in either group, although cholesterol and triglyceride levels decreased significantly in the NVP arm.

The triglyceride and cholesterol reductions among patients receiving NVP suggests that PI use is associated with metabolic abnormalities. The fact that these reductions were observed despite the use of d4T + ddI therapy shows that these agents are not major contributors to these metabolic abnormalities. However, the follow up time was short; increased differences may be observed over a longer period of follow up and as more patients are enrolled in the study.