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Abstract
Effects of Highly Active antiretroviral Therapy on free testosterone (Tfree) levels and fat-free mass (FFM ) in men in a prospective, randomized trial
M. Dubé1, R. Parker2, K. Mulligan3, P. Tebas4, G. Robbins5, S. Grinspoon6, AIDS Clinical Trials Group A5005s and 384 Study Teams
Background: Hypogonadism with low testosterone levels is commonly reported in HIV and associated with advanced disease. The effects of initiating antiretrovirals on testosterone levels and their association with changes in FFM over time have not been reported.
Methods: A subset of antiretroviral-naive subjects randomized to nelfinavir, efavirenz, or both with ZDV+3TC or ddI+d4T had evaluation of metabolic parameters and bioelectrical impedance analysis (BIA) over 64 weeks. Tfree was measured by equilibrium dialysis. Subjects receiving testosterone supplements were excluded from this intent-to-treat analysis.
Results: Among 217 men at baseline, median Tfree levels were 94 pg/mL (IQR 71,120) and were subnormal (<50) in 6%. Tfree increased at week 16, 32, and 64 (+16, +14, and +15 pg/mL respectively, each p<0.01). Tfree increased more with ZDV+3TC (N=50, +30 pg/mL) than with ddI+d4T (N=58, +1 ) at week 64 (p=0.002, Wilcoxon rank-sum) and increased more with efavirenz (N=39, +30) than nelfinavir (N=29, -5, p=0.047). Median FFM by BIA increased by 1.3 kg for the whole group at week 64 (+2.2%, p<0.001). FFM tended to increase more with ZDV+3TC (N=84, +2.9%) than ddI+d4T (N=101, +1.1%, p=0.08) and increased more with efavirenz (N=66, +3.3%) than nelfinavir (N=57, +0.7%, p=0.01). At week 64, changes in Tfree weakly correlated with changes in FFM (Spearman r=0.21, p=0.04) but baseline Tfree and week 16 changes did not. Entry CD4 (r=-0.38, p <0.001) and HIV RNA (r=0.30, p<0.001) also correlated with the week 64 change in FFM.
Conclusions: Subnormal Tfree levels occurred infrequently among these antiretroviral-naive subjects. Tfree increased after initiating antiretrovirals, with greater increases with ZDV+3TC vs ddI+d4T, and efavirenz vs nelfinavir at 64 weeks. Increases in Tfree were weakly associated with increased FFM and thus may be responsible in part for the greater relative FFM increases with ZDV+3TC or efavirenz.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
THPE0121
Suggested Citation
"M.Dubé, et al.
Effects of Highly Active antiretroviral Therapy on free testosterone (Tfree) levels and fat-free mass (FFM ) in men in a prospective, randomized trial.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
THPE0121"
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