Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341172
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2006-06-19
Brief Title:
The Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Discovery of Genetic Variants Contributing to the Incidence or Course of CMV Disease in AIDS Patients
Status:
COMPLETED
Status Verified Date:
2021-03
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:
This study will evaluate the role of certain gene variants on the onset and course of cytomegalovirus CMV retinitis-a severe infection affecting the eye-in patients with AIDS Symptoms include blurry vision eye pain photophobia floaters eye redness and impaired vision Left untreated it can cause blindness The study is done in collaboration with investigators of the Longitudinal Studies of the Ocular Complications of AIDS LSOCA at the Johns Hopkins University School of Medicine The purpose of the LSOCA study is to learn about how HIV and other infections associated with AIDS and their treatments affect peoples eyes and sight
Blood samples previously collected from patients participating in the LSOCA study will be analyzed for gene variants These differences will then be correlated with the patients clinical data to try to discover the role of gene differences among patients on the following susceptibility to CMV and related problems development and course of CMV and response to HAART highly active antiretroviral treatment particularly in CMV onset and pathology
The study will use blood samples and clinical information previously collected from patients during their participation in LSOCA The materials will be identified with a numerical code linking the samples and clinical data No additional procedures will be performed on patients for this study
Blood samples previously collected from patients participating in the LSOCA study will be analyzed for gene variants These differences will then be correlated with the patients clinical data to try to discover the role of gene differences among patients on the following susceptibility to CMV and related problems development and course of CMV and response to HAART highly active antiretroviral treatment particularly in CMV onset and pathology
The study will use blood samples and clinical information previously collected from patients during their participation in LSOCA The materials will be identified with a numerical code linking the samples and clinical data No additional procedures will be performed on patients for this study
Detailed Description:
Background
LSOCA is a prospective observational study of ocular complications in HIV-infected AIDS patients including those treated with highly active anti-retroviral treatment HAART
In the absence of HAART there is a 30 risk of cytomegalovirus CMV0 infection associated with AIDS
Of these CMV patients 75-85 will develop retinitis
Objectives
Test a number of human candidate gene polymorphisms in the LSOCA cohort samples to discover genetic influences on the susceptibility to CMV and associated pathologies
Inspect the role of known AIDS restriction genes ARGs on the infection and pathogenesis of CMV
Evaluate the role of the same host gene polymorphisms on the response to HAART particularly in CMV onset and pathology
Eligibility
Lymphocytes for DNA extraction and relevant clinical data from properly consented AIDS patients maximum estimated at n 2000 will be provided to the LGD for genotyping and analysis No available subjects will be excluded
Design
LSOCA has collected blood specimens and banked viably frozen lymphocytes from each study participant Samples and clinical data are coded and linked
Genes under study include the traditional described ARGs OBrien Nelson 2004 the CMV receptor gene US28 Pleskoff et al 1997 HLA class I and II KIR gene family and other genes involved in virus immune defenses
Single nucleotide variants within coding regions upstream and downstream regulatory regions and ironic elements will be tested for genetic equilibrium distortion in patient populations at risk for CMV and displaying CMV pathology
Following this study the samples will be maintained in our repository and curated through our central Laboratory database Loss or destruction of these samples will be recorded in our database and cannot impact the study participants in any way We understand that studies subsequent to the completion of this protocol will require additional OHSRIRB approval prior to commencement
LSOCA is a prospective observational study of ocular complications in HIV-infected AIDS patients including those treated with highly active anti-retroviral treatment HAART
In the absence of HAART there is a 30 risk of cytomegalovirus CMV0 infection associated with AIDS
Of these CMV patients 75-85 will develop retinitis
Objectives
Test a number of human candidate gene polymorphisms in the LSOCA cohort samples to discover genetic influences on the susceptibility to CMV and associated pathologies
Inspect the role of known AIDS restriction genes ARGs on the infection and pathogenesis of CMV
Evaluate the role of the same host gene polymorphisms on the response to HAART particularly in CMV onset and pathology
Eligibility
Lymphocytes for DNA extraction and relevant clinical data from properly consented AIDS patients maximum estimated at n 2000 will be provided to the LGD for genotyping and analysis No available subjects will be excluded
Design
LSOCA has collected blood specimens and banked viably frozen lymphocytes from each study participant Samples and clinical data are coded and linked
Genes under study include the traditional described ARGs OBrien Nelson 2004 the CMV receptor gene US28 Pleskoff et al 1997 HLA class I and II KIR gene family and other genes involved in virus immune defenses
Single nucleotide variants within coding regions upstream and downstream regulatory regions and ironic elements will be tested for genetic equilibrium distortion in patient populations at risk for CMV and displaying CMV pathology
Following this study the samples will be maintained in our repository and curated through our central Laboratory database Loss or destruction of these samples will be recorded in our database and cannot impact the study participants in any way We understand that studies subsequent to the completion of this protocol will require additional OHSRIRB approval prior to commencement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N023 | None | None | None |