Abstract

The primary purpose of this project is to determine whether multiple intramuscular injections of the APL 400-003 HIV DNA plasmid vaccine at dose levels of 30, 100, and 300 micrograms can be administered safely to asymptomatic HIV-infected patients. As a secondary objective, the protocol is designed to evaluate whether these multiple intramuscular injections of the APL 400-003 Vaccine might enhance existing antigen-specific immune responses, especially T cell responses, when administered to asymptomatic HIV-infected patients and to characterize the immune response profile of these patients pre- and post-injection, and to monitor indicators of progression of HIV infection in these asymptomatic HIV-infected patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000040-36
Application #
5216093
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
36
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Khalili, Mandana; Shuhart, Margaret C; Lombardero, Manuel et al. (2018) Relationship Between Metabolic Syndrome, Alanine Aminotransferase Levels, and Liver Disease Severity in a Multiethnic North American Cohort With Chronic Hepatitis B. Diabetes Care 41:1251-1259
Thomas, Bernadette; Matsushita, Kunihiro; Abate, Kalkidan Hassen et al. (2017) Global Cardiovascular and Renal Outcomes of Reduced GFR. J Am Soc Nephrol 28:2167-2179
Ojiro, Keisuke; Qu, Xiaowang; Cho, Hyosun et al. (2017) Modulation of Hepatitis C Virus-Specific CD8 Effector T-Cell Function with Antiviral Effect in Infectious Hepatitis C Virus Coculture Model. J Virol 91:
Di Bisceglie, A M; Lombardero, M; Teckman, J et al. (2017) Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat 24:320-329
Lok, A S; Ganova-Raeva, L; Cloonan, Y et al. (2017) Prevalence of hepatitis B antiviral drug resistance variants in North American patients with chronic hepatitis B not receiving antiviral treatment. J Viral Hepat 24:1032-1042
Leonard, Mary B; Shults, Justine; Long, Jin et al. (2016) Effect of Low-Magnitude Mechanical Stimuli on Bone Density and Structure in Pediatric Crohn's Disease: A Randomized Placebo-Controlled Trial. J Bone Miner Res 31:1177-88
Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N et al. (2016) National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 65:3418-3428
Evon, Donna M; Wahed, Abdus S; Johnson, Geoffrey et al. (2016) Fatigue in Patients with Chronic Hepatitis B Living in North America: Results from the Hepatitis B Research Network (HBRN). Dig Dis Sci 61:1186-96
Park, Jang-June; Wong, David K; Wahed, Abdus S et al. (2016) Hepatitis B Virus--Specific and Global T-Cell Dysfunction in Chronic Hepatitis B. Gastroenterology 150:684-695.e5
Hering, Bernhard J; Clarke, William R; Bridges, Nancy D et al. (2016) Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 39:1230-40

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