Abstract

The Monoclonal Antibody CMV Retinitis Trial has, as its primary objective, the comparison of the safety and efficacy of Human Anti-CMV Monoclonal Antibody (MSL 109) plus active primary treatment versus matched placebo plus active primary treatment for both newly diagnosed and relapsed CMV retinitis in patients with AIDS. The 325 patient trial will use a two-stage group sequential design in which the results from 76 patients enrolled and evaluated in the first stage will trigger a review of the Policy and Data Monitoring Board to determine whether to proceed to the full recruitment goal as planned, modify the trial, or terminate the trial. The design variables for the first stage are change in CMV virologic load and time to progression of retinitis. The design variable for the overall trial is time to progression of retinitis. Additional outcome measures include mortality, adverse events, change in visual acuity, and change in visual fields.

  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 #
6458590
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

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