The Body Covers: The 6th Conference on Retroviruses and Opportunistic Infections
Late Breaker No. LB14: A Multi-Center, Randomized, Open-Label, Comparative Trial of the Clinical Benefit of Switching the Protease Inhibitor by Nevirapine in HAART-Experienced Patients Suffering Lipodystrophy
February 4, 1999
The growing problem of serum lipid abnormalities and profound changes in the distribution of body fat -- otherwise coined lipodystrophy -- is continuing to receive attention at these meetings both from a standpoint of understanding the underlying mechanisms, as well as from a therapeutic one. To date, physicians have no well-defined means of managing this complication comprehensively. Lipid abnormalities like elevated triglycerides and cholesterol must be managed with dietary maneuvers and lipid-lowering agents in order to avoid the consequences of inflammation of the pancreas (though pancreatitis is still very uncommon in the seting of HIV and hypertryglyceridemia) and cardiovascular events like stroke and heart disease. The profound alterations in the distribution of body fat present their own therapeutic challenges as they may be quite disfiguring and uncomfortable. Since lipodystrophy (LD) is most often associated with protease inhibitor use, one approach to managing the problem is to replace the offending PI with a suitably active drug that has not been associated with LD. This trial (and others) attempts to quantify the anticipated benefit of such a therapeutic maneuver.
Dr. Ruiz and colleagues enrolled 62 individuals suffering from LD in this open label multicenter study, selecting those who have been receiving D4T, 3TC and a PI for more than 9 months, have CD4 counts greater than 100 and who have achieved undetectable levels of virus in their blood (<400 copies/ml). These individuals were then randomized to either one of two groups:
Participants were assessed every 4 weeks to watch for possible rebound in viral load, and measures of LD were determined at baseline and every three months. The data reported here summarizes their findings 12 weeks into the study, and the study is ongoing.
In the 21 patients who have reached the 12 week point (11 in NVP group and 10 in PI group), viral load has remained under 400 copies/ml, and there has been no decrease in CD4 counts. In the NVP group, the mean serum cholesterol diminished significantly (from 230 + 46 to 196 + 54, p<0.05), and triglyceride levels diminshed but not to levels that reached statistical significance. Unfortunately at this early point in the study, no objective improvement in body fat measures (through sophisticated DEXA scanning and BIA testing) were seen, though both physician's and patient's estimation of body shape changes improved significantly in the NVP group. Only by allowing the passage of more time will it become clear whether this treatment strategy is effective in managing LD.
Authored by: L. Ruiz, A. Bonjoch, R. Paredes, S. Johnston, A. Arno, J. Romeu, M. Balague, G. Sierra, A. Tuldra, A.C. Fumaz, and B. Clotet for the LD Study Group
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