The testing of the experimental drug, recombinant interleukin-2, in patients with HIV infections. There will be two study groups involved in taking different doses of the drug, and one group that will take none of the drug. The study will determine if the use of subcutaneous recombinant IL-2 (proleukin) results in higher CD4 cell counts (count that lowers with HIV virus) in patients infected with HIV, but having a CD4 count of at least 350/mm^3. Normal CD4 count is 1,000-1,500/mm^3. It will also determine if raising the CD4 count will reduce the viral load and lengthen the time until the development of AIDS. The study will also look at two different doses of IL-2 to determine differences in side effects, toxicity stimulation of CD4 counts compliance by the patients. Patients will be recruited from the individual practices of the physicians in the Richmond AIDS Consortium (RAC). Each patient will be randomly assigned to one of the three study groups. Group 1 will receive an injection below the skin of a lower dose of IL-2 for several days, twice a day. Then the patient will have no IL-2 for many weeks. Then another session of IL-2 administration will occur. After a respite of several weeks, a third session will take place. Depending on the results based on the CD4+ count, doses may be continued. Group two will follow the same schedule as group one, but at a higher dose of IL-2. Group three will receive no IL-2. All three groups are encouraged to continue usage of HIV medications while participating in the study. Group 1 and 2 patients are required to take HIV medication, one day before, during, and nine days after the injections of IL-2. During the study, patients will return to the CRC once a month for the first 12 months, and then, every four months until the completion of the study. At monthly visits, 2-3 tablespoons of blood will be drawn for routine and special tests as well as for a future test. There will be questions about health and medications of the patients and a physical exam every four months.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000065-38
Application #
6419253
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
Holkova, Beata; Yazbeck, Victor; Kmieciak, Maciej et al. (2017) A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leuk Lymphoma 58:1349-1357
Corey, Kathleen E; Vuppalanchi, Raj; Vos, Miriam et al. (2015) Improvement in liver histology is associated with reduction in dyslipidemia in children with nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr 60:360-7
Eaton, J E; Juran, B D; Atkinson, E J et al. (2015) A comprehensive assessment of environmental exposures among 1000 North American patients with primary sclerosing cholangitis, with and without inflammatory bowel disease. Aliment Pharmacol Ther 41:980-90
Worthington Jr, Everett L; Berry, Jack W; Hook, Joshua N et al. (2015) Forgiveness-reconciliation and communication-conflict-resolution interventions versus retested controls in early married couples. J Couns Psychol 62:14-27
Holkova, Beata; Kmieciak, Maciej; Perkins, E Brent et al. (2014) Phase I trial of bortezomib (PS-341; NSC 681239) and ""nonhybrid"" (bolus) infusion schedule of alvocidib (flavopiridol; NSC 649890) in patients with recurrent or refractory indolent B-cell neoplasms. Clin Cancer Res 20:5652-62
Lo, D J; Farris, A B; Song, M et al. (2013) Inhibition of ?v?6 promotes acute renal allograft rejection in nonhuman primates. Am J Transplant 13:3085-93
Jones, Robert; Vuky, Jacqueline; Elliott, Tony et al. (2013) Phase II study to assess the efficacy, safety and tolerability of the mitotic spindle kinesin inhibitor AZD4877 in patients with recurrent advanced urothelial cancer. Invest New Drugs 31:1001-7
Al Hawaj, M A; Martin, E J; Venitz, J et al. (2013) Monitoring rFVIII prophylaxis dosing using global haemostasis assays. Haemophilia 19:409-14
Noureddin, Mazen; Yates, Katherine P; Vaughn, Ivana A et al. (2013) Clinical and histological determinants of nonalcoholic steatohepatitis and advanced fibrosis in elderly patients. Hepatology 58:1644-54
Lo, D J; Anderson, D J; Weaver, T A et al. (2013) Belatacept and sirolimus prolong nonhuman primate renal allograft survival without a requirement for memory T cell depletion. Am J Transplant 13:320-8

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