HIV Infections Clinical Trial
To conduct a multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer blood donors from areas of the United States that were reportedly at high and medium or low risk for HIV. Also, to determine the prevalence of retrovirus seropositivity in first time blood donors; and the rate of retrovirus seroconversion in repeat blood donors as a measure of incidence of infection; to ascertain risk factors for antibody-positive donors; to characterize the blood donor population by geographic location, age, sex, race/ethnicity, and donation history to permit analysis on prevalence, incidence, and risk factors; to identify recipients of retrovirus-positive blood units and conduct clinical and laboratory follow-up of these recipients; and to establish a blood specimen repository for long-term storage of specimens from study donors and recipients for future testing.
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 100 Years |
Eligibility | No eligibility criteria |
N/A
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Heart, Lung, and Blood Institute (NHLBI) |
Busch MP, Glynn SA, Schreiber GB. Potential increased risk of virus transmission due to exclusion of older donors because of concern over Creutzfeldt-Jakob disease. The National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. Transfusion. 1997 Oct;37(10):996-1002. — View Citation
Busch MP, Glynn SA, Stramer SL, Strong DM, Caglioti S, Wright DJ, Pappalardo B, Kleinman SH; NHLBI-REDS NAT Study Group. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion. 2005 Feb;45(2):254-64. — View Citation
Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA. 2003 Feb 26;289(8):959-62. — View Citation
Busch MP, Kleinman SH, Williams AE, Smith JW, Ownby HE, Laycock ME, Lee LL, Pau CP, Schreiber GB. Frequency of human immunodeficiency virus (HIV) infection among contemporary anti-HIV-1 and anti-HIV-1/2 supplemental test-indeterminate blood donors. The Retrovirus Epidemiology Donor Study. Transfusion. 1996 Jan;36(1):37-44. — View Citation
Busch MP, Korelitz JJ, Kleinman SH, Lee SR, AuBuchon JP, Schreiber GB. Declining value of alanine aminotransferase in screening of blood donors to prevent posttransfusion hepatitis B and C virus infection. The Retrovirus Epidemiology Donor Study. Transfusion. 1995 Nov-Dec;35(11):903-10. — View Citation
Busch MP, Laycock M, Kleinman SH, Wages JW Jr, Calabro M, Kaplan JE, Khabbaz RF, Hollingsworth CG. Accuracy of supplementary serologic testing for human T-lymphotropic virus types I and II in US blood donors. Retrovirus Epidemiology Donor Study. Blood. 1994 Feb 15;83(4):1143-8. — View Citation
Busch MP, Watanabe KK, Smith JW, Hermansen SW, Thomson RA. False-negative testing errors in routine viral marker screening of blood donors. For the Retrovirus Epidemiology Donor Study. Transfusion. 2000 May;40(5):585-9. — View Citation
Busch MP. [Residual risks of viral transmission by transfusions and projected yields of additional screening tests. Retrovirus Epidemiology Donors Study (REDS)]. Transfus Clin Biol. 1996;3(1):7-11. French. Erratum in: Transfus Clin Biol 1996;3(2):134. — View Citation
Damesyn MA, Glynn SA, Schreiber GB, Ownby HE, Bethel J, Fridey J, McMullen Q, Garratty G, Busch MP; NHLBI Retrovirus Epidemiology Donor Study. Behavioral and infectious disease risks in young blood donors: implications for recruitment. Transfusion. 2003 Nov;43(11):1596-603. — View Citation
Dinwiddie FW. Humanistic behaviorism: a model for rapprochement in residential treatment milieus. Child Psychiatry Hum Dev. 1975 Summer;5(4):254-9. — View Citation
Glynn SA, Busch MP, Schreiber GB, Murphy EL, Wright DJ, Tu Y, Kleinman SH; NHLBI REDS Study Group. Effect of a national disaster on blood supply and safety: the September 11 experience. JAMA. 2003 May 7;289(17):2246-53. — View Citation
Glynn SA, Kleinman SH, Schreiber GB, Busch MP, Wright DJ, Smith JW, Nass CC, Williams AE. Trends in incidence and prevalence of major transfusion-transmissible viral infections in US blood donors, 1991 to 1996. Retrovirus Epidemiology Donor Study (REDS). JAMA. 2000 Jul 12;284(2):229-35. — View Citation
Glynn SA, Schreiber GB, Busch MP, Kleinman SH, Williams AE, Nass CC, Ownby HE, Smith JW. Demographic characteristics, unreported risk behaviors, and the prevalence and incidence of viral infections: a comparison of apheresis and whole-blood donors. The Retrovirus Epidemiology Donor Study. Transfusion. 1998 Apr;38(4):350-8. — View Citation
Glynn SA, Smith JW, Schreiber GB, Kleinman SH, Nass CC, Bethel J, Biswas B, Thomson RA, Williams AE; Retrovirus Epidemiology Donor Study. Repeat whole-blood and plateletpheresis donors:unreported deferrable risks, reactive screening tests, andresponse to incentive programs. Transfusion. 2001 Jun;41(6):736-43. — View Citation
Glynn SA, Williams AE, Nass CC, Bethel J, Kessler D, Scott EP, Fridey J, Kleinman SH, Schreiber GB; Retrovirus Epidemiology Donor Study. Attitudes toward blood donation incentives in the United States: implications for donor recruitment. Transfusion. 2003 Jan;43(1):7-16. — View Citation
Guiltinan AM, Murphy EL, Horton JA, Nass CC, McEntire RL, Watanabe K. Psychological distress in blood donors notified of HTLV-I/II infection. Retrovirus Epidemiology Donor Study. Transfusion. 1998 Nov-Dec;38(11-12):1056-62. — View Citation
Heneine W, Switzer WM, Busch M, Khabbaz RF, Kaplan JE. Molecular subtyping of human T-cell lymphotropic virus type 2 by single-strand conformation polymorphism analysis. Retrovirus Epidemiology Donor Study Group. J Clin Microbiol. 1995 Dec;33(12):3260-3. — View Citation
Johnson D, Hirschkorn D, Busch MP. Evaluation of four alternative methodologies for determination of absolute CD4+ lymphocyte counts. The National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Dec 15;10(5):522-30. — View Citation
Kaplan JE, Khabbaz RF, Murphy EL, Hermansen S, Roberts C, Lal R, Heneine W, Wright D, Matijas L, Thomson R, Rudolph D, Switzer WM, Kleinman S, Busch M, Schreiber GB. Male-to-female transmission of human T-cell lymphotropic virus types I and II: association with viral load. The Retrovirus Epidemiology Donor Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Jun 1;12(2):193-201. — View Citation
Kleinman S, Busch MP, Hall L, Thomson R, Glynn S, Gallahan D, Ownby HE, Williams AE. False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation. Retrovirus Epidemiology Donor Study. JAMA. 1998 Sep 23-30;280(12):1080-5. — View Citation
Kleinman S, Glynn SA, Busch M, Todd D, Powell L, Pietrelli L, Nemo G, Schreiber G, Bianco C, Katz L; NHLBI Retrovirus Epidemiology Study (REDS). The 2003 West Nile virus United States epidemic: the America's Blood Centers experience. Transfusion. 2005 Apr;45(4):469-79. — View Citation
Kleinman SH, Glynn SA, Higgins MJ, Triulzi DJ, Smith JW, Nass CC, Garratty G, Murphy EL, LeParc GF, Schreiber GB, King MR, Chamberland ME, Nemo GJ. The RADAR repository: a resource for studies of infectious agents and their transmissibility by transfusion. Transfusion. 2005 Jul;45(7):1073-83. — View Citation
Kleinman SH, Kaplan JE, Khabbaz RF, Calabro MA, Thomson R, Busch M. Evaluation of a p21e-spiked western blot (immunoblot) in confirming human T-cell lymphotropic virus type I or II infection in volunteer blood donors. The Retrovirus Epidemiology Donor Study Group. J Clin Microbiol. 1994 Mar;32(3):603-7. — View Citation
Kleinman SH, Kuhns MC, Todd DS, Glynn SA, McNamara A, DiMarco A, Busch MP; Retrovirus Epidemiology Donor Study. Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion transmission and donor screening. Transfusion. 2003 Jun;43(6):696-704. — View Citation
Korelitz JJ, Busch MP, Kleinman SH, Williams AE, Gilcher RO, Ownby HE, Schreiber GB. A method for estimating hepatitis B virus incidence rates in volunteer blood donors. National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. Transfusion. 1997 Jun;37(6):634-40. — View Citation
Korelitz JJ, Busch MP, Williams AE. Antigen testing for human immunodeficiency virus (HIV) and the magnet effect: will the benefit of a new HIV test be offset by the numbers of higher risk, test-seeking donors attracted to blood centers? Retrovirus Epidemiology Donor Study. Transfusion. 1996 Mar;36(3):203-8. — View Citation
Korelitz JJ, Williams AE, Busch MP, Zuck TF, Ownby HE, Matijas LJ, Wright DJ. Demographic characteristics and prevalence of serologic markers among donors who use the confidential unit exclusion process: the Retrovirus Epidemiology Donor Study. Transfusion. 1994 Oct;34(10):870-6. — View Citation
Liu H, Leung P, Glynn S, Murphy EL. Human T-lymphotropic virus type II RFLP subtypes a0 and b4/b5 are associated with different demographic and geographic characteristics in the United States. Virology. 2001 Jan 5;279(1):90-6. — View Citation
Murphy EL, Bryzman SM, Glynn SA, Ameti DI, Thomson RA, Williams AE, Nass CC, Ownby HE, Schreiber GB, Kong F, Neal KR, Nemo GJ. Risk factors for hepatitis C virus infection in United States blood donors. NHLBI Retrovirus Epidemiology Donor Study (REDS). Hepatology. 2000 Mar;31(3):756-62. — View Citation
Murphy EL, Fridey J, Smith JW, Engstrom J, Sacher RA, Miller K, Gibble J, Stevens J, Thomson R, Hansma D, Kaplan J, Khabbaz R, Nemo G. HTLV-associated myelopathy in a cohort of HTLV-I and HTLV-II-infected blood donors. The REDS investigators. Neurology. 1997 Feb;48(2):315-20. — View Citation
Murphy EL, Glynn S, Watanabe K, Fridey J, Smith J, Sacher R, Wright D, Schreiber G, Luban N. Laboratory test differences associated with HTLV-I and HTLV-II infection. Retrovirus Epidemiology Donor Study Investigators. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Apr 1;17(4):332-8. — View Citation
Murphy EL, Glynn SA, Fridey J, Sacher RA, Smith JW, Wright DJ, Newman B, Gibble JW, Ameti DI, Nass CC, Schreiber GB, Nemo GJ. Increased prevalence of infectious diseases and other adverse outcomes in human T lymphotropic virus types I- and II-infected blood donors. Retrovirus Epidemiology Donor Study (REDS) Study Group. J Infect Dis. 1997 Dec;176(6):1468-75. — View Citation
Murphy EL, Glynn SA, Fridey J, Smith JW, Sacher RA, Nass CC, Ownby HE, Wright DJ, Nemo GJ. Increased incidence of infectious diseases during prospective follow-up of human T-lymphotropic virus type II- and I-infected blood donors. Retrovirus Epidemiology Donor Study. Arch Intern Med. 1999 Jul 12;159(13):1485-91. — View Citation
Ownby HE, Kong F, Watanabe K, Tu Y, Nass CC. Analysis of donor return behavior. Retrovirus Epidemiology Donor Study. Transfusion. 1999 Oct;39(10):1128-35. — View Citation
Ownby HE, Korelitz JJ, Busch MP, Williams AE, Kleinman SH, Gilcher RO, Nourjah P. Loss of volunteer blood donors because of unconfirmed enzyme immunoassay screening results. Retrovirus Epidemiology Donor Study. Transfusion. 1997 Feb;37(2):199-205. — View Citation
Pellett PE, Wright DJ, Engels EA, Ablashi DV, Dollard SC, Forghani B, Glynn SA, Goedert JJ, Jenkins FJ, Lee TH, Neipel F, Todd DS, Whitby D, Nemo GJ, Busch MP; Retrovirus Epidemiology Donor Study. Multicenter comparison of serologic assays and estimation of human herpesvirus 8 seroprevalence among US blood donors. Transfusion. 2003 Sep;43(9):1260-8. — View Citation
Roback JD, Drew WL, Laycock ME, Todd D, Hillyer CD, Busch MP. CMV DNA is rarely detected in healthy blood donors using validated PCR assays. Transfusion. 2003 Mar;43(3):314-21. — View Citation
Rugege-Hakiza SE, Glynn SA, Hutching ST, Bethel J, Nass CC, McEntire RL, Hirschler NV, Campbell JG, Ladavac A, Schreiber GB; Retrovirus Epidemiology Donor Study. Do blood donors read and understand screening educational materials? Transfusion. 2003 Aug;43(8):1075-83. — View Citation
Sacher RA, Luban NL, Ameti DI, Friend S, Schreiber GB, Murphy EL. Low prevalence of flower cells in U.S.A. blood donors infected with human T-lymphotrophic virus types I and II. Br J Haematol. 1999 Jun;105(3):758-63. — View Citation
Sanchez AM, Ameti DI, Schreiber GB, Thomson RA, Lo A, Bethel J, Williams AE; Retrovirus Epidemiology Donor Study. The potential impact of incentives on future blood donation behavior. Transfusion. 2001 Feb;41(2):172-8. — View Citation
Sanchez AM, Schreiber GB, Bethel J, McCurdy PR, Glynn SA, Williams AE, Gilcher R; Retrovirus Epidemiology Donor Study (REDS). Prevalence, donation practices, and risk assessment of blood donors with hemochromatosis. JAMA. 2001 Sep 26;286(12):1475-81. — View Citation
Sanchez AM, Schreiber GB, Glynn SA, Bethel J, Kessler D, Chang D, Zuck TF; Retrovirus Epidemiology Donor Study. Blood-donor perceptions of health history screening with a computer-assisted self-administered interview. Transfusion. 2003 Feb;43(2):165-72. — View Citation
Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med. 1996 Jun 27;334(26):1685-90. — View Citation
Schreiber GB, Glynn SA, Damesyn MA, Wright DJ, Tu Y, Dodd RY, Murphy EL; Retrovirus Epidemiology Donor Study. Lapsed donors: an untapped resource. Transfusion. 2003 Jan;43(1):17-24. — View Citation
Schreiber GB, Murphy EL, Horton JA, Wright DJ, Garfein R, Chien HC, Nass CC. Risk factors for human T-cell lymphotropic virus types I and II (HTLV-I and -II) in blood donors: the Retrovirus Epidemiology Donor Study. NHLBI Retrovirus Epidemiology Donor Study. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Mar 1;14(3):263-71. — View Citation
Schreiber GB, Sanchez AM, Garratty G, Nass CC, Tu Y, Busch MP; Retrovirus Epidemiology Donor Study. Mammalian brain consumption by blood donors in the United States: brains today, deferred tomorrow? Transfusion. 2004 May;44(5):667-74. — View Citation
Schreiber GB, Sanchez AM, Glynn SA, Wright DJ; Retrovirus Epidemiology Donor Study. Increasing blood availability by changing donation patterns. Transfusion. 2003 May;43(5):591-7. — View Citation
Sharma UK, Stramer SL, Wright DJ, Glynn SA, Hermansen S, Schreiber GB, Kleinman SH, Busch MP; Retrovirus Epidemiology Donor Study. Impact of changes in viral marker screening assays. Transfusion. 2003 Feb;43(2):202-14. — View Citation
Thomson RA, Bethel J, Lo AY, Ownby HE, Nass CC, Williams AE. Retention of "safe" blood donors. The Retrovirus Epidemiology Donor Study. Transfusion. 1998 Apr;38(4):359-67. — View Citation
Tobler LH, Bianco C, Glynn SA, Schreiber GB, Dille BJ, Prince HE, Lanciotti RS, Linnen JM, Gallarda J, Shyamala V, Smith D, Kleinman SH, Busch MP; NHLBI Retrovirus Epidemiology Study (REDS). Detection of West Nile virus RNA and antibody in frozen plasma components from a voluntary market withdrawal during the 2002 peak epidemic. Transfusion. 2005 Apr;45(4):480-6. — View Citation
Tobler LH, Lee SR, Stramer SL, Peterson J, Kochesky R, Watanabe K, Quan S, Polito A, Busch MP. Performance of second- and third-generation RIBAs for confirmation of third-generation HCV EIA-reactive blood donations. Retrovirus Epidemiology Donor Study. Transfusion. 2000 Aug;40(8):917-23. — View Citation
Wang B, Schreiber GB, Glynn SA, Nass CC, Smith JW, Higgins MJ, Hutching ST, Wright DJ, McEntire RL, Murphy EL; Retrovirus Epidemiology Donor Study. Prevalence of transfusion-transmissible viral infections in first-time US blood donors by donation site. Transfusion. 2003 Jun;43(6):705-12. — View Citation
Watanabe KK, Williams AE, Schreiber GB, Ownby HE. Infectious disease markers in young blood donors. Retrovirus Epidemiology Donor Study. Transfusion. 2000 Aug;40(8):954-60. — View Citation
Williams AE, Thomson RA, Schreiber GB, Watanabe K, Bethel J, Lo A, Kleinman SH, Hollingsworth CG, Nemo GJ. Estimates of infectious disease risk factors in US blood donors. Retrovirus Epidemiology Donor Study. JAMA. 1997 Mar 26;277(12):967-72. — View Citation
Wu Y, Glynn SA, Schreiber GB, Wright DJ, Lo A, Murphy EL, Kleinman SH, Garratty G; Retrovirus Epidemiology Donor Study (REDS) Group. First-time blood donors: demographic trends. Transfusion. 2001 Mar;41(3):360-4. Erratum in: Transfusion 2001 May;41(5):721. — View Citation
Zuck TF, Thomson RA, Schreiber GB, Gilcher RO, Kleinman SH, Murphy EL, Ownby HE, Williams AE, Busch MP, Smith JW, et al. The Retrovirus Epidemiology Donor Study (REDS): rationale and methods. Transfusion. 1995 Nov-Dec;35(11):944-51. — View Citation
* Note: There are 56 references in all — Click here to view all references
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