Abstract

This study is a 24 week randomized 3 arm multi-center open label trial in Saquinavir (hard capsule) experienced patients. These HIV infected patients will be randomized to receive either a continuation of the hard capsule or arm 2- the new soft gelatin capsule of saquinavir which will replace the SQVhc in their drug regimen or arm 3- indinavir which will replace the Saquinavir hard capsule in their drug regimen. Subjects will continue on their same non-protease anti-HIV drugs, if on any therapy. At 8 weeks, subjects receiving SQVhc will be switched to open label Indinavir for weeks 8-24. Subjects receiving Saquinavir soft gel capsule and subjects receiving Indinavir will continue on their randomized therapy for 24 weeks unless they have no virologic response to their new therapy. Viral RNA levels will be obtained pre, during and post study enrollment.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR005096-09S1
Application #
6298304
Study Section
Project Start
1997-12-01
Project End
1999-06-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
9
Fiscal Year
1999
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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