The trace element, selenium, is essential for maintaining a viable and responsive immune system. Administered as a chemopreventive agent, it has been shown to significantly reduce cancer mortality and be protective against a number of viral pathogens in a variety of clinical settings. Recent reports indicate that selenium is predictive of HIV-1 related prognosis, and may have an important role in preventing HIV-1 replication. Our studies in HIV-1 seropositive drug users demonstrate that selenium is a powerful predictor of HIV-1 disease progression and mortality. These compelling findings suggest that selenium administered as a chemopreventive agent may effectively modulate HIV disease progression. Our previous experience and a review of the literature indicate that selenium in nutritional doses is feasible and safe in HIV-1 infected individuals. The proposed study is a randomized, double-blind, controlled clinical trial comparing the effects of selenium or placebo in HIV-1 infected male and female drug users. A total of 328 HIV-1 infected adults will be randomized into the trial. At six month intervals, laboratory and clinical markers of disease progression will be evaluated, as well as selenium status, and specific drug use. Compliance to the intervention and potential toxicity will be monitored throughout the trial. This proposed investigation will permit us to determine whether supplemental selenium, as a chemopreventive agent, can enhance the immune system and reduce viral load to slow HIV-1 disease progression in male and female drug users.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA011378-04
Application #
6174696
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Khalsa, Jagjitsingh H
Project Start
1997-09-30
Project End
2003-07-31
Budget Start
2001-08-01
Budget End
2003-07-31
Support Year
4
Fiscal Year
2000
Total Cost
$152,437
Indirect Cost
Name
University of Miami Coral Gables
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
625174149
City
Coral Gables
State
FL
Country
United States
Zip Code
33146
Miguez-Burbano, Maria Jose; Burbano, Ximena; Ashkin, David et al. (2003) Impact of tobacco use on the development of opportunistic respiratory infections in HIV seropositive patients on antiretroviral therapy. Addict Biol 8:39-43
Shor-Posner, Gail; Miguez, Maria-Jose; Pineda, Luisa Maria et al. (2002) Impact of selenium status on the pathogenesis of mycobacterial disease in HIV-1-infected drug users during the era of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 29:169-73
Burbano, Ximena; Miguez-Burbano, Maria Jose; McCollister, Kathryn et al. (2002) Impact of a selenium chemoprevention clinical trial on hospital admissions of HIV-infected participants. HIV Clin Trials 3:483-91
Miguez-Burbano, M J; Burbano, X; Rodriguez, A et al. (2002) Development of thrombocytosis in HIV+ drug users: impact of antiretroviral therapy. Platelets 13:183-5
Miguez, Maria Jose; Burbano, Ximena; Archer, Harry et al. (2002) Limited impact of highly active antiretroviral therapy in thrombocytopenia. J Acquir Immune Defic Syndr 30:260-1
Burbano, X; Miguez, M J; Lecusay, R et al. (2001) Thrombocytopenia in HIV-infected drug users in the HAART era. Platelets 12:456-61
Lai, H; Lai, S; Shor-Posner, G et al. (2001) Plasma zinc, copper, copper:zinc ratio, and survival in a cohort of HIV-1-infected homosexual men. J Acquir Immune Defic Syndr 27:56-62
Zhao, L; Cox, A G; Ruzicka, J A et al. (2000) Molecular modeling and in vitro activity of an HIV-1-encoded glutathione peroxidase. Proc Natl Acad Sci U S A 97:6356-61
Taylor, E W; Cox, A G; Zhao, L et al. (2000) Nutrition, HIV, and drug abuse: the molecular basis of a unique role for selenium. J Acquir Immune Defic Syndr 25 Suppl 1:S53-61
Shor-Posner, G; Campa, A; Zhang, G et al. (2000) When obesity is desirable: a longitudinal study of the Miami HIV-1-infected drug abusers (MIDAS) cohort. J Acquir Immune Defic Syndr 23:81-8