By Brian Boyle, MD

The results of the FRAMS-2 study were presented by R Murphy at the XIV World AIDS Conference. This is a substudy of the Atlantic trial, a study that involved a backbone of Videx and Zerit combined with either Crixivan (indinavir), Viramune (nevirapine) or Epivir (lamivudine; 3TC) in 298 treatment-naïve patients.

This substudy began at week 72 of the trial and involves 69 patients on their original treatment regimen. The study involved a number of tests including CT scans, DEXA scans, BIAs and body energy expenditure (BEE) measurements. The investigators found that 49.3% of the patients developed mild-to-severe lipoatrophy (by report) and 24.6% moderate-to-severe fat accumulation.

Visceral adipose tissue accumulations were greater in the Crixivan arm versus the other arms of the study, but there was no difference in subcutaneous adipose tissue between the 3 arms. Further, BIA and REE measurements were the same between the 3 arms. Finally, there was no significant difference in any of the lab parameters.

The authors conclude from these data that “There was no significant difference in fat distribution between the [3 different] treatment arms, suggesting that in the first 2-3 years of therapy in [patients] on the same NRTI backbone, no significant differences between treatment approaches occurs.”

Of course, as pointed out, this study is limited by having the same NRTI backbone in all 3 arms, a relatively small sample size, and the fact that it is a cross-sectional analysis done late in the patients’ treatment course.

07/17/02

Reference

R Murphy and others. Fat redistribution and metabolic changes with a nucleoside reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study. WeOrB1306. Program and Abstracts of the XIV International AIDS Conference. July 7-12, 2002. Barcelona, Spain.