This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator.
SPECIFIC AIMS : Primary Objective: To evaluate whether treatment with growth hormone plus HAART is associated with increased percentage of Nanve CD4+ lymphocytes compared with treatment with HAART alone at 24 weeks. Secondary Objectives: Secondary efficacy objectives mainly refer to changes from baseline to week 24. However, it is also of interest to examine changes from baseline to week 48, and changes over the first 24 weeks of growth hormone (baseline to week 24 for Arm A and from week 24 to week 48 for Arm B). To evaluate whether treatment with growth hormone therapy is associated with changes in absolute number of Nanve CD4+ cells. To evaluate whether treatment with growth hormone therapy is associated with changes in CD4+ cell count. To evaluate whether treatment with growth hormone is associated with increases in thymic output as measured by frequency of T-cell receptor excision circles (TREC) in peripheral blood lymphocytes in HIV-infected adults. To evaluate whether treatment with growth hormone is associated with improved responses to HIV antigens, neoantigens (KLH), and hepatitis A vaccine in HIV infected adults. To evaluate the effect of growth hormone on interleukin-7 (IL-7) levels. To evaluate safety of 1.5 mg/day and 3 mg/day growth hormone therapy in HIV-infected subjects. To compare the tolerability of growth hormone at 1.5 mg/day for 24 weeks and 48 weeks versus 3 mg/day for 24 weeks.
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