Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005278
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2000-05-25
Brief Title:
Retrovirus Epidemiology Donor Study I REDS I
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 raceethnicity 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
Detailed Description:
BACKGROUND
HIV is known to be transmissible by blood blood components or plasma derivatives The risk of contracting HIV infection from blood transfusion has been greatly reduced in the United States by implementing stringent criteria for donor acceptance HIV antibody screening and new methods of virus inactivation in coagulation factor concentrates There are additional human retroviruses however that may pose a threat to the safety of the nations blood supply
The human T-cell lymphotropic retroviruses share many properties including a preferred tropism for certain lymphocytes and similar modes of transmission They also differ significantly from each other and on this basis are divided into two distinct groups the human T-cell lymphocytropic viruses HTLVs and the human immunodeficiency viruses HIVs HTLV-I a transforming virus is the prototype of the first group HTLVs It is associated with adult T-cell leukemia ATL and is thought to be involved in a central nervous system disorder referred to as tropical spastic paraparesis This group also includes HTLV-II which is associated with a T-cell malignancy different from ATL A newly isolated human retrovirus termed HTLV-V may be the etiologic agent of cutaneous T-cell lymphomaleukemia and may also be added to this group HIV previously known as HTLV-III or lymphadenopathy virus LAV a nontransforming virus causes acquired immunodeficiency syndrome AIDS and is the prototype of the second group HIVs New members of this group of nontransforming human retroviruses were isolated from individuals in different countries of Africa LAV-2 also referred to as HIV-2 was isolated from two AIDS patients in Africa and the first case of AIDS in the United States caused by HIV-2 was reported in January 1988 A third member of this group HIV-3 was detected in Africa
Although the HTLV family of retroviruses is distinct from the HIV family both groups of viruses infect human T4 CD4 lymphocytes preferentially and alter the hosts T-cell functions Whereas HTLV-I or HTLV-II primarily induce transformation and proliferation of T Lymphocytes and cause T-cell lymphomaleukemia in humans HIV and HIV-2 induce T-cell cytopathology that leads to depletion of CD4 cells
The spread of HIV by blood transfusion represents a highly efficient mode of transmission Blood components from donors with antibody to HIV have been shown to transmit the virus with frequencies of greater than 90 percent Packed red blood cells platelets or fresh frozen plasma are all equally effective in transmitting the virus to recipients It is highly likely therefore that recipients who receive blood from donors with antibody to HIV will themselves become infected with the virus Fortunately the likelihood of such an occurrence in the United States is now rare due to the implementation of screening procedures and other safeguards When the study was initiated in 1989 there was a growing concern however that human retroviruses other than HIV might threaten the safety of the United States blood supply
DESIGN NARRATIVE
Blood donors were asked to participate in this multicenter study Seropositive donors were notified of test results counseled and invited to join the follow-up study Data collected during the first interview included such items as possible exposures to persons with retroviral infection sexual preferences and contacts marital history intravenous drug use occupation travel knowledge of AIDS and routes of HIV transmission At subsequent visits a blood specimen was collected for laboratory testing and an assessment made of changes in behavior to reduce the risk of virus transmission
To calculate incidence and prevalence rates each center identified the appropriate study population for analysis purposes in collaboration with the coordinating center For prevalence calculations the study population consisted of donors at all centers who indicated that they had never donated blood previously To calculate incidence the study population consisted of donors who had donated previously in the same center The incidence of retroviral infections was assessed annually in years three through five Clinical follow-up of all subjects concluded 48 months after the beginning of enrollment A blood profile for each center was required to calculate denominator values for incidence and prevalence determinations The blood profile or donor demographic characterization consisted of information regarding total donor volume with respect to donation status new or repeat donor and if repeat the time of last donation age sex and race
An adjunct to the study was the development of repositories of plasma and cell samples from infected donors and negative controls collected at the same time A potential byproduct of these repositories will be the ability in future years to retrospectively search the REDS frozen repository file for new retroviruses which may appear in the United States population
HIV is known to be transmissible by blood blood components or plasma derivatives The risk of contracting HIV infection from blood transfusion has been greatly reduced in the United States by implementing stringent criteria for donor acceptance HIV antibody screening and new methods of virus inactivation in coagulation factor concentrates There are additional human retroviruses however that may pose a threat to the safety of the nations blood supply
The human T-cell lymphotropic retroviruses share many properties including a preferred tropism for certain lymphocytes and similar modes of transmission They also differ significantly from each other and on this basis are divided into two distinct groups the human T-cell lymphocytropic viruses HTLVs and the human immunodeficiency viruses HIVs HTLV-I a transforming virus is the prototype of the first group HTLVs It is associated with adult T-cell leukemia ATL and is thought to be involved in a central nervous system disorder referred to as tropical spastic paraparesis This group also includes HTLV-II which is associated with a T-cell malignancy different from ATL A newly isolated human retrovirus termed HTLV-V may be the etiologic agent of cutaneous T-cell lymphomaleukemia and may also be added to this group HIV previously known as HTLV-III or lymphadenopathy virus LAV a nontransforming virus causes acquired immunodeficiency syndrome AIDS and is the prototype of the second group HIVs New members of this group of nontransforming human retroviruses were isolated from individuals in different countries of Africa LAV-2 also referred to as HIV-2 was isolated from two AIDS patients in Africa and the first case of AIDS in the United States caused by HIV-2 was reported in January 1988 A third member of this group HIV-3 was detected in Africa
Although the HTLV family of retroviruses is distinct from the HIV family both groups of viruses infect human T4 CD4 lymphocytes preferentially and alter the hosts T-cell functions Whereas HTLV-I or HTLV-II primarily induce transformation and proliferation of T Lymphocytes and cause T-cell lymphomaleukemia in humans HIV and HIV-2 induce T-cell cytopathology that leads to depletion of CD4 cells
The spread of HIV by blood transfusion represents a highly efficient mode of transmission Blood components from donors with antibody to HIV have been shown to transmit the virus with frequencies of greater than 90 percent Packed red blood cells platelets or fresh frozen plasma are all equally effective in transmitting the virus to recipients It is highly likely therefore that recipients who receive blood from donors with antibody to HIV will themselves become infected with the virus Fortunately the likelihood of such an occurrence in the United States is now rare due to the implementation of screening procedures and other safeguards When the study was initiated in 1989 there was a growing concern however that human retroviruses other than HIV might threaten the safety of the United States blood supply
DESIGN NARRATIVE
Blood donors were asked to participate in this multicenter study Seropositive donors were notified of test results counseled and invited to join the follow-up study Data collected during the first interview included such items as possible exposures to persons with retroviral infection sexual preferences and contacts marital history intravenous drug use occupation travel knowledge of AIDS and routes of HIV transmission At subsequent visits a blood specimen was collected for laboratory testing and an assessment made of changes in behavior to reduce the risk of virus transmission
To calculate incidence and prevalence rates each center identified the appropriate study population for analysis purposes in collaboration with the coordinating center For prevalence calculations the study population consisted of donors at all centers who indicated that they had never donated blood previously To calculate incidence the study population consisted of donors who had donated previously in the same center The incidence of retroviral infections was assessed annually in years three through five Clinical follow-up of all subjects concluded 48 months after the beginning of enrollment A blood profile for each center was required to calculate denominator values for incidence and prevalence determinations The blood profile or donor demographic characterization consisted of information regarding total donor volume with respect to donation status new or repeat donor and if repeat the time of last donation age sex and race
An adjunct to the study was the development of repositories of plasma and cell samples from infected donors and negative controls collected at the same time A potential byproduct of these repositories will be the ability in future years to retrospectively search the REDS frozen repository file for new retroviruses which may appear in the United States population
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: