Abstract

This is a randomized open-label trial to compare the effects of two doses of subcutaneous (SC) recombinant IL-2 (rIL-2) and no rIL-2 on HIV viral burden and CD4+ cell count in patients with HIV-1 infection and absolute CD4 cell counts of > 350/mm3. Study participants will be either currently receiving or initiating antiretroviral treatment prior to randomization. If the international phase III clinical endpoint trial of SC rIL-2 is implemented, patients enrolled in this CPCRA study will be strongly encouraged to enroll and receive continued treatment and follow-up in the international study. The total sample size is 460 patients. Two hundred and thirty patients will randomized to one of two doses of SC rIL-2 therapy (4.5 MIU or 7.5 MIU twice daily), and 230 patients will be randomized to no SC rIL-2 over an anticipated enrollment period of 12 months.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-12
Application #
6458542
Study Section
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
12
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118

  Publications

Allegrezza, Michael J; Rutkowski, Melanie R; Stephen, Tom L et al. (2016) Trametinib Drives T-cell-Dependent Control of KRAS-Mutated Tumors by Inhibiting Pathological Myelopoiesis. Cancer Res 76:6253-6265
Drerup, Justin M; Liu, Yang; Padron, Alvaro S et al. (2015) Immunotherapy for ovarian cancer. Curr Treat Options Oncol 16:317
Chyun, Deborah A; Wackers, Frans J Th; Inzucchi, Silvio E et al. (2015) Autonomic dysfunction independently predicts poor cardiovascular outcomes in asymptomatic individuals with type 2 diabetes in the DIAD study. SAGE Open Med 3:2050312114568476
Rahman, Mahboob; Xie, Dawei; Feldman, Harold I et al. (2014) Association between chronic kidney disease progression and cardiovascular disease: results from the CRIC Study. Am J Nephrol 40:399-407
Kempen, John H; Sugar, Elizabeth A; Varma, Rohit et al. (2014) Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology 121:2317-24
Ricardo, Ana C; Yang, Wei; Lora, Claudia M et al. (2014) Limited health literacy is associated with low glomerular filtration in the Chronic Renal Insufficiency Cohort (CRIC) study. Clin Nephrol 81:30-7
Kozak, Igor; Vaidya, Vijay; Van Natta, Mark L et al. (2014) The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis. Invest Ophthalmol Vis Sci 55:4304-12
Wing, Maria R; Devaney, Joseph M; Joffe, Marshall M et al. (2014) DNA methylation profile associated with rapid decline in kidney function: findings from the CRIC study. Nephrol Dial Transplant 29:864-72
Mariani, Laura H; White, Matthew T; Shults, Justine et al. (2014) Increasing use of vitamin D supplementation in the chronic renal insufficiency cohort study. J Ren Nutr 24:186-93
Wing, Maria R; Yang, Wei; Teal, Valerie et al. (2014) Race modifies the association between adiposity and inflammation in patients with chronic kidney disease: findings from the chronic renal insufficiency cohort study. Obesity (Silver Spring) 22:1359-66

Showing the most recent 10 out of 211 publications