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Abstract
Treatment with growth hormone leads to improvement in total and naïve CD4 lymphocyte recovery in HIV-infected subjects with incomplete immune reconstitution on HAART
Smith K.1, Wang R.2, Bosch R.2, Margolis D.3, Tenorio A.1, Pollard R.4, Stocker V.5, Gross B.6, Frances I.6, Muurahainen N.7, ACTG 5174 Protocol Team A.5
1Rush University Medical Center, Chicago, United States of America, 2Harvard School of Public Health, Boston, United States of America, 3UT Southwestern Medical Center, Dallas, United States of America, 4UC Davis Medical Center, San Diego, United States of America, 5AACTG Operations Center, Silver Spring, United States of America, 6University of Michigan, Ann Arbor, United States of America, 7Serono, Inc, Rockland, United States of America
Objectives: To evaluate the immunologic effects of recombinant growth hormone (rGH) on HIV+ subjects with incomplete immune reconstitution on HAART.
Methods: Sixty subjects on HAART were randomized to receive rGH 1.5mg SC QD +HAART for 48 weeks (ARM A) or continue HAART alone for 24 wks followed by addition of rGH 3.0 mg SC QD for 24 wks (ARM B). Eleven subjects in ARM A underwent thymus CT scans at baseline and wk 24 to evaluate thymus size. Statistical comparisons were made using Wilcoxon signed-rank.
Results: All subjects had been on HAART for > 1 year, entry CD4<350 and VL<400 and maintained VL <400 c/ml through week 48. Baseline median total CD4 for ARM A and B were 223 and 219, respectively. Six subjects went off study prior to week 48. Arm A trended toward increases in total (p=0.054) and naïve (p=0.099) CD4 cell count from baseline to week 24 while ARM B had no significant change. By wk 48, both arms had significant increases in total and naïve CD4 cells. From baseline to week 48, median change in total and naive CD4 for ARM A and B were +36, +26 and +55, +23 respectively (p< 0.002 for each). In ARM B, the median change in naïve CD4 # from BL to wk 24 (HAART alone) was 5, the change from wk 24 to 48 (HAART + rGH) was 24, (median difference in changes: 24; p<0.001). Seven of 11 (64%) in ARM A had increased thymus size from baseline to week 24 (p=0.06).
Conclusions: Treatment with rGH is associated with significant increases in total and naïve CD4 count compared to HAART alone. Treatment with rGH is associated with an increase in thymus size. This is the first randomized clinical trial to demonstrate immunologic effects of rGH combined with HAART.
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