Acquired Immunodeficiency SyndromeNCT00005278
Retrovirus Epidemiology Donor Study I (REDS I)
An observational study of Acquired Immunodeficiency Syndrome and Blood Donors, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Blood Donors, Blood Transfusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1989to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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 nation's 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 lymphoma/leukemia, 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 host's T-cell functions. Whereas HTLV-I or HTLV-II primarily induce transformation and proliferation of T Lymphocytes and cause T-cell lymphoma/leukemia 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.
- Conditions
- Acquired Immunodeficiency Syndrome, Blood Donors, Blood Transfusion, HIV Infections, HIV-1, HIV-2
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Retroviridae Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1989
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- George Garratty, American Red Cross Blood ServicesMartha Higgens, American Red Cross Blood ServicesEdward Murphy, University of California at San FranciscoCatharie Nass, American Red Cross Blood ServicesGeorge Schreiber, Westat, Inc.James Smith, Oklahoma Blood Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005278
- Sponsor's protocol ID
- 1501
- Status last verified
- Jan 2008
- First submitted
- 25 May 2000
- Last updated
- 15 Apr 2016
- Results posted
- No
Publications
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. doi: 10.1046/j.1537-2995.1997.371098016436.x.
PubMed 9354816Busch 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. doi: 10.1046/j.1537-2995.1996.36196190513.x.
PubMed 8607151Zuck 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. doi: 10.1046/j.1537-2995.1995.351196110900.x. No abstract available.
PubMed 8604493Busch 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. doi: 10.1046/j.1537-2995.1995.351196110893.x.
PubMed 8604486Korelitz 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. doi: 10.1046/j.1537-2995.1996.36396182135.x.
PubMed 8604502Heneine 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. doi: 10.1128/jcm.33.12.3260-3263.1995.
PubMed 8586713Johnson 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.
PubMed 8548331Korelitz 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. doi: 10.1046/j.1537-2995.1994.341095026972.x.
PubMed 7940658Kleinman 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. doi: 10.1128/jcm.32.3.603-607.1994.
PubMed 8195365Busch 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.
PubMed 8111054Schreiber 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. doi: 10.1056/NEJM199606273342601.
PubMed 8637512Korelitz 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. doi: 10.1046/j.1537-2995.1997.37697335159.x.
PubMed 9191825Schreiber 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. doi: 10.1097/00042560-199703010-00011.
PubMed 9117460Williams 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.
PubMed 9091668Ownby 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. doi: 10.1046/j.1537-2995.1997.37297203524.x.
PubMed 9051096
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrovirus Epidemiology Donor Study I (REDS I)
- ClinicalTrials.gov ID
- NCT00005278
- Acronym / sponsor ID
- 1501
- Conditions
- Acquired Immunodeficiency Syndrome, Blood Donors, Blood Transfusion, HIV Infections, HIV-1, HIV-2
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1989
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 nation's 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 lymphoma/leukemia, 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 host's T-cell functions. Whereas HTLV-I or HTLV-II primarily induce transformation and proliferation of T Lymphocytes and cause T-cell lymphoma/leukemia 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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 9354816Busch 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. doi: 10.1046/j.1537-2995.1997.371098016436.x.
- Background: PubMed 8607151Busch 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. doi: 10.1046/j.1537-2995.1996.36196190513.x.
- Background: PubMed 8604493Zuck 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. doi: 10.1046/j.1537-2995.1995.351196110900.x. No abstract available.
- Background: PubMed 8604486Busch 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. doi: 10.1046/j.1537-2995.1995.351196110893.x.
- Background: PubMed 8604502Korelitz 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. doi: 10.1046/j.1537-2995.1996.36396182135.x.
- Background: PubMed 8586713Heneine 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. doi: 10.1128/jcm.33.12.3260-3263.1995.
- Background: PubMed 8548331Johnson 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.
- Background: PubMed 7940658Korelitz 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. doi: 10.1046/j.1537-2995.1994.341095026972.x.
- Background: PubMed 8195365Kleinman 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. doi: 10.1128/jcm.32.3.603-607.1994.
- Background: PubMed 8111054Busch 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.
- Background: PubMed 8637512Schreiber 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. doi: 10.1056/NEJM199606273342601.
- Background: PubMed 9191825Korelitz 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. doi: 10.1046/j.1537-2995.1997.37697335159.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Garratty
American Red Cross Blood Services
Martha Higgens
American Red Cross Blood Services
Edward Murphy
University of California at San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome and Blood Donors, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005278, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.