AIDSNCT00341172
The Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis
An observational study of AIDS, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 100 years
- Conditions the study is for
- AIDS
- How many people
- 2,232 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2004to 4 Mar 2021
- 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 13 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CMV Disease in AIDS cohort@@@@@@
Who may be able to join
- Lymphocytes for DNA and relevant clinical data from properly consented subjects will be provided to the LGD for genotyping and analysis. No available subjects will be excluded.
- Diagnosis of AIDS according to the 1993 CDC diagnostic criteria (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS).
- Age 13 years or older
- Signed consent statement
- For minors, ages 13-17, signed Consent Statement (by parent/guardian) and Assent Statement (by adolescent and parent/guardian).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovery of Genetic Variants Contributing to the Incidence or Course of CMV Disease in AIDS Patients
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 people's 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.
Read the 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= 2,000) 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 (O'Brien \& 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 OHSR/IRB approval prior to commencement.
- Conditions
- AIDS
- Keywords
- Retinitis, Cytomegalovirus, HIV-1, Polymorphisms, HAART
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Retinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of 2500 samples
this study is complete
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 start26 Oct 2004
- Primary completion30 Jun 2011
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,232 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
- NCT00341172
- Sponsor's protocol ID
- 999905023
- Other IDs
- 05-C-N023
- Status last verified
- Mar 2021
- First submitted
- 19 Jun 2006
- Last updated
- 5 Mar 2021
- Results posted
- No
Publications
O'Brien SJ, Nelson GW, Winkler CA, Smith MW. Polygenic and multifactorial disease gene association in man: Lessons from AIDS. Annu Rev Genet. 2000;34:563-591. doi: 10.1146/annurev.genet.34.1.563.
PubMed 11092839O'Brien SJ, Moore JP. The effect of genetic variation in chemokines and their receptors on HIV transmission and progression to AIDS. Immunol Rev. 2000 Oct;177:99-111. doi: 10.1034/j.1600-065x.2000.17710.x.
PubMed 11138790Jabs DA, Van Natta ML, Kempen JH, Reed Pavan P, Lim JI, Murphy RL, Hubbard LD. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2002 Jan;133(1):48-61. doi: 10.1016/s0002-9394(01)01322-8.
PubMed 11755839
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Genetic Variants Contributing to the Incidence or Course of CMV Disease in AIDS Patients
- ClinicalTrials.gov ID
- NCT00341172
- Acronym / sponsor ID
- 999905023
- Conditions
- AIDS
- Keywords
- Retinitis, Cytomegalovirus, HIV-1, Polymorphisms, HAART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,232 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Oct 2004 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 4 Mar 2021 (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.
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 people's 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.
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= 2,000) 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 (O'Brien \& 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 OHSR/IRB approval prior to commencement.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CMV Disease in AIDS cohort@@@@@@
Key inclusion criteria (5 listed)
- Lymphocytes for DNA and relevant clinical data from properly consented subjects will be provided to the LGD for genotyping and analysis. No available subjects will be excluded.
- Diagnosis of AIDS according to the 1993 CDC diagnostic criteria (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS).
- Age 13 years or older
- Signed consent statement
- For minors, ages 13-17, signed Consent Statement (by parent/guardian) and Assent Statement (by adolescent and parent/guardian).
Key exclusion criteria (0 listed)
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
Collection of 2500 samples
Time frame: Annually
this study is complete
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 5 Mar 2021.
- Background: PubMed 11092839O'Brien SJ, Nelson GW, Winkler CA, Smith MW. Polygenic and multifactorial disease gene association in man: Lessons from AIDS. Annu Rev Genet. 2000;34:563-591. doi: 10.1146/annurev.genet.34.1.563.
- Background: PubMed 11138790O'Brien SJ, Moore JP. The effect of genetic variation in chemokines and their receptors on HIV transmission and progression to AIDS. Immunol Rev. 2000 Oct;177:99-111. doi: 10.1034/j.1600-065x.2000.17710.x.
- Background: PubMed 11755839Jabs DA, Van Natta ML, Kempen JH, Reed Pavan P, Lim JI, Murphy RL, Hubbard LD. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2002 Jan;133(1):48-61. doi: 10.1016/s0002-9394(01)01322-8.
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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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS, run by National Cancer Institute (NCI) at 1 site 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
What does the primary outcome measure?
Collection of 2500 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 NCT00341172, which also lists 3 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 5 Mar 2021.