HemophiliaNCT00340548
Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3)
An observational study of Hemophilia and AIDS, run by National Cancer Institute (NCI) at 15 sites in United States.
Trial summary
Background: Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections. Read more about this study
- Who is it for?
- Ages 4 to 100 years
- Conditions the study is for
- Hemophilia, AIDS
- How many people
- 333 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Apr 2002to 9 Jan 2020
- 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 4 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The current Study will involve analysis of existing samples (DNA, serum, cells, plasma) and data. The entire set of 333 subjects in the HGDS cohort will be analyzed.
Who cannot join
- No subjects will be excluded from the HGDS cohort.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Wayne State University Hutzel Hospital
Detroit, Michigan, 48201
NCI Frederick Cancer Research Center
Frederick, Maryland, 21702-1201
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033-2390
University of Texas, Houston
Houston, Texas, 77225
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, 46260
University of Iowa
Iowa City, Iowa, 52242-1101
Childrens Mercy Hospital
Kansas City, Missouri
University of California, San Diego
La Jolla, California, 92093-0603
Childrens Hospital, Los Angeles
Los Angeles, California, 90054-0700
Tulane University
New Orleans, Louisiana, 70112-2699
Cornell University
New York, New York, 10021-4872
Mt. Sinai Medical Center
New York, New York, 10029-0574
University of Oklahoma
Oklahoma City, Oklahoma
University of Nebraska
Omaha, Nebraska, 68198-7830
University of Texas, San Antonio
San Antonio, Texas, 78229-3900
About this study
Background:
Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections.
Read more
Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression.
Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens is becoming increasingly common, particularly amongst intravenous drug users, who account for approximately 25% of the HIV-1 epidemic in the United States.
Objectives:
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical progression of HIV1 to AIDS in hemophiliacs.
Eligibility:
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study (HGDS).
Design:
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study (HGDS) as part of a grant "Pathogenesis of HIV and HCV in Hemophilia: HGDS-3" with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.
This multicenter, United States study represents a well-characterized, prospectively followed cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.
Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or clinical data will be collected on this population.
The LGD plays two roles in this project: (1) an administrative role overseeing the withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication..
Read the detailed description
Background:
Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections.
Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression.
Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens is becoming increasingly common, particularly amongst intravenous drug users, who account for approximately 25% of the HIV-1 epidemic in the United States.
Objectives:
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical progression of HIV1 to AIDS in hemophiliacs.
Eligibility:
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study (HGDS).
Design:
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study (HGDS) as part of a grant "Pathogenesis of HIV and HCV in Hemophilia: HGDS-3" with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.
This multicenter, United States study represents a well-characterized, prospectively followed cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.
Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or clinical data will be collected on this population.
The LGD plays two roles in this project: (1) an administrative role overseeing the withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication..
- Conditions
- Hemophilia, AIDS
- Keywords
- Genotyping, Polymorphisms, Co-Infection, Chemokines, Associations, HIV, HCV, Hepatitis C, Hemophilia
- Medical subject headings
- Hemophilia A, Acquired Immunodeficiency Syndrome, Coinfection, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of 333 samples
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start9 Apr 2002
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Why it stopped: lapse in IRB review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel W McVicar, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340548
- Sponsor's protocol ID
- 999902173
- Other IDs
- 02-C-N173
- Status last verified
- Jan 2020
- First submitted
- 19 Jun 2006
- Last updated
- 13 Jan 2020
- Results posted
- No
Publications
Dean M, Carrington M, Winkler C, Huttley GA, Smith MW, Allikmets R, Goedert JJ, Buchbinder SP, Vittinghoff E, Gomperts E, Donfield S, Vlahov D, Kaslow R, Saah A, Rinaldo C, Detels R, O'Brien SJ. Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study. Science. 1996 Sep 27;273(5283):1856-62. doi: 10.1126/science.273.5283.1856.
PubMed 8791590Daar ES, Lynn H, Donfield S, Gomperts E, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Relation between HIV-1 and hepatitis C viral load in patients with hemophilia. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):466-72. doi: 10.1097/00126334-200104150-00011.
PubMed 11391167Daar ES, Lynn H, Donfield S, Gomperts E, O'Brien SJ, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Hepatitis C virus load is associated with human immunodeficiency virus type 1 disease progression in hemophiliacs. J Infect Dis. 2001 Feb 15;183(4):589-95. doi: 10.1086/318539. Epub 2001 Jan 12.
PubMed 11170984Hilgartner MW, Donfield SM, Willoughby A, Contant CF Jr, Evatt BL, Gomperts ED, Hoots WK, Jason J, Loveland KA, McKinlay SM, et al. Hemophilia growth and development study. Design, methods, and entry data. Am J Pediatr Hematol Oncol. 1993 May;15(2):208-18. doi: 10.1097/00043426-199305000-00009.
PubMed 8498644
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3)
- ClinicalTrials.gov ID
- NCT00340548
- Acronym / sponsor ID
- 999902173
- Conditions
- Hemophilia, AIDS
- Keywords
- Genotyping, Polymorphisms, Co-Infection, Chemokines, Associations, HIV, HCV, Hepatitis C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lapse in IRB review
- Enrolment
- 333 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Apr 2002
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 21 Jun 2006 (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.
Background:
Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections.
Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression.
Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens is becoming increasingly common, particularly amongst intravenous drug users, who account for approximately 25% of the HIV-1 epidemic in the United States.
Objectives:
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical progression of HIV1 to AIDS in hemophiliacs.
Eligibility:
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study (HGDS).
Design:
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study (HGDS) as part of a grant "Pathogenesis of HIV and HCV in Hemophilia: HGDS-3" with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.
This multicenter, United States study represents a well-characterized, prospectively followed cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.
Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or clinical data will be collected on this population.
The LGD plays two roles in this project: (1) an administrative role overseeing the withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication..
Detailed description
Background:
Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic viral infections.
Moreover, the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression.
Although the hemophiliac poulation is unique, co-infection by these chronic viral pathogens is becoming increasingly common, particularly amongst intravenous drug users, who account for approximately 25% of the HIV-1 epidemic in the United States.
Objectives:
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with (1) intracellular cytokines levels in CD4 + Tcells, (2) Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) viral loads, and (3) clinical progression of HIV1 to AIDS in hemophiliacs.
Eligibility:
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study (HGDS).
Design:
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study (HGDS) as part of a grant "Pathogenesis of HIV and HCV in Hemophilia: HGDS-3" with funding support by NIH/NICHD for the period 9/25/01 through 8/31/2005.
This multicenter, United States study represents a well-characterized, prospectively followed cohort of HCV-infected hemophiliacs, of whom 207 are HIV-1 co-infected.
Enrollment of the hemophiliac cohort was completed between 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. No new samples or clinical data will be collected on this population.
The LGD plays two roles in this project: (1) an administrative role overseeing the withdrawal, handling, and transport of samples from the HGDS/LGD and central repositories at the NCI-Frederick, and (2) a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The current Study will involve analysis of existing samples (DNA, serum, cells, plasma) and data. The entire set of 333 subjects in the HGDS cohort will be analyzed.
Key exclusion criteria (1 listed)
- No subjects will be excluded from the HGDS cohort.
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
Receipt of 333 samples
Time frame: Annually
Results and safety
The study was stopped early (reason given: lapse in IRB review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 8791590Dean M, Carrington M, Winkler C, Huttley GA, Smith MW, Allikmets R, Goedert JJ, Buchbinder SP, Vittinghoff E, Gomperts E, Donfield S, Vlahov D, Kaslow R, Saah A, Rinaldo C, Detels R, O'Brien SJ. Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study. Science. 1996 Sep 27;273(5283):1856-62. doi: 10.1126/science.273.5283.1856.
- Background: PubMed 11391167Daar ES, Lynn H, Donfield S, Gomperts E, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Relation between HIV-1 and hepatitis C viral load in patients with hemophilia. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):466-72. doi: 10.1097/00126334-200104150-00011.
- Background: PubMed 11170984Daar ES, Lynn H, Donfield S, Gomperts E, O'Brien SJ, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Hepatitis C virus load is associated with human immunodeficiency virus type 1 disease progression in hemophiliacs. J Infect Dis. 2001 Feb 15;183(4):589-95. doi: 10.1086/318539. Epub 2001 Jan 12.
- Background: PubMed 8498644Hilgartner MW, Donfield SM, Willoughby A, Contant CF Jr, Evatt BL, Gomperts ED, Hoots WK, Jason J, Loveland KA, McKinlay SM, et al. Hemophilia growth and development study. Design, methods, and entry data. Am J Pediatr Hematol Oncol. 1993 May;15(2):208-18. doi: 10.1097/00043426-199305000-00009.
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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.
Daniel W McVicar, Ph.D. principal investigator
National Cancer Institute (NCI)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia and AIDS, run by National Cancer Institute (NCI) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: lapse in IRB review). Results are not available in the source record.
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.
What does the primary outcome measure?
Receipt of 333 samples (time frame: Annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340548, which also lists 4 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 13 Jan 2020.