HIV-1NCT00340223
HLA-B35 Alleles and AIDS
An observational study of HIV-1 and AIDS, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2005to Sep 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sera and relevant clinical data from properly consented HIV positive seroconverters will be provided to the LGD for analysis. No available subjects will be excluded to maximize power. We will request an accrual ceiling of 100 participants.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
John Hopkins Bloomberg School of Public Health
Baltimore, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Northwestern University
Chicago, Illinois, 60611
Howard Brown Health Center
Chicago, Illinois, 60613
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois
University of California, Los Angeles
Los Angeles, California, 90095
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Comparison of HIV-1 Epitopes That May be Recognized by HLA-B*3501 (PY) and -B*3503 (Px) Early After Seroconversion and After Development of AIDS
This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B*3501 and B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.)
HIV disease in people with the B*3503 allele progresses significantly faster than it does in people with the B*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine.
Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.
Read the detailed description
The purpose of this study is to identify variations in the genome of HIV early after infection and following the development of AIDS to determine the location of escape mutations that might provide information about potential B*35 epitopes. These data will be useful in explaining the difference in disease progression between individuals possessing B*35 Px alleles and those with B*35 PY alleles. We have previously shown that individuals with B*35 Px alleles progress at a significantly faster rate compared to those with B*35 PY alleles. This study might provide information which is potentially useful in the development of a successful HIV vaccine.
- Keywords
- Immunity, Mutations, Viral Selection, Disease Progression, RNA
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Disease Progression
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 startSep 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340223
- Sponsor's protocol ID
- 999905237
- Other IDs
- 05-C-N237
- Status last verified
- May 2012
- First submitted
- 19 Jun 2006
- Last updated
- 10 May 2012
- Results posted
- No
Publications
Kiepiela P, Leslie AJ, Honeyborne I, Ramduth D, Thobakgale C, Chetty S, Rathnavalu P, Moore C, Pfafferott KJ, Hilton L, Zimbwa P, Moore S, Allen T, Brander C, Addo MM, Altfeld M, James I, Mallal S, Bunce M, Barber LD, Szinger J, Day C, Klenerman P, Mullins J, Korber B, Coovadia HM, Walker BD, Goulder PJ. Dominant influence of HLA-B in mediating the potential co-evolution of HIV and HLA. Nature. 2004 Dec 9;432(7018):769-75. doi: 10.1038/nature03113.
PubMed 15592417
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HIV-1 Epitopes That May be Recognized by HLA-B*3501 (PY) and -B*3503 (Px) Early After Seroconversion and After Development of AIDS
- ClinicalTrials.gov ID
- NCT00340223
- Acronym / sponsor ID
- 999905237
- Keywords
- Immunity, Mutations, Viral Selection, Disease Progression, RNA
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2005
- Study completion
- Sep 2007 (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 identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B*3501 and B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.)
HIV disease in people with the B*3503 allele progresses significantly faster than it does in people with the B*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine.
Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.
Detailed description
The purpose of this study is to identify variations in the genome of HIV early after infection and following the development of AIDS to determine the location of escape mutations that might provide information about potential B*35 epitopes. These data will be useful in explaining the difference in disease progression between individuals possessing B*35 Px alleles and those with B*35 PY alleles. We have previously shown that individuals with B*35 Px alleles progress at a significantly faster rate compared to those with B*35 PY alleles. This study might provide information which is potentially useful in the development of a successful HIV vaccine.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sera and relevant clinical data from properly consented HIV positive seroconverters will be provided to the LGD for analysis. No available subjects will be excluded to maximize power. We will request an accrual ceiling of 100 participants.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Background: PubMed 15592417Kiepiela P, Leslie AJ, Honeyborne I, Ramduth D, Thobakgale C, Chetty S, Rathnavalu P, Moore C, Pfafferott KJ, Hilton L, Zimbwa P, Moore S, Allen T, Brander C, Addo MM, Altfeld M, James I, Mallal S, Bunce M, Barber LD, Szinger J, Day C, Klenerman P, Mullins J, Korber B, Coovadia HM, Walker BD, Goulder PJ. Dominant influence of HLA-B in mediating the potential co-evolution of HIV and HLA. Nature. 2004 Dec 9;432(7018):769-75. doi: 10.1038/nature03113.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 and AIDS, run by National Cancer Institute (NCI) at 7 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 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: withdrawn, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 withdrawn before enrolling participants, so there are no results.
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 NCT00340223, which also lists 1 linked publication.
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 10 May 2012.