HIVNCT00339430
HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women (WIHS)
An observational study of HIV, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being conducted in several cities in the United States to learn more about how HIV affects women's lives and bodies. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV
- How many people
- 3,500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2002to 18 Aug 2010
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DNA and relevant clinical data from properly consented WIHS subjects (maximum estimated at 3500) will be provided to our lab for genotyping and analysis.
Who cannot join
- No available subjects will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being conducted in several cities in the United States to learn more about how HIV affects women's lives and bodies. It will examine the role of HLA and killer immunoglobulin-like receptors (KIR) in HIV and related infections in HIV-positive and HIV-negative women. The study will determine the relationship between KIR and HLA genes and the following: the risk of HIV infection; HIV levels in the blood; incidence of AIDS; response to highly active antiretroviral therapy (HAART); and response to immunotherapy.
Approximately 3,700 women will participate. Participants will visit the clinic every 6 months for 4 years. An HIV test will be given each time to HIV-negative women. A questionnaire will also be administered. A physical examination and gynecological examination will be given. Blood, vaginal swabs, and urine will be collected for testing. A biological impedance test will determine any changes in weight, waist-to-hip ratios, and breast and total body fat. Low CD4 counts and hospitalizations for HIV are to be self-reported to study staff.
Read the detailed description
The aim of the study is to examine the role of HLA and killer immunolobulin-like receptors (KIR) in the natural history of HPV, HCV, and HBV in HIV-positive and HIV-negative women. The immune response to viral infection mediated by T lymphocytes is HLA restricted, suggesting that HLA class I, and class II might be associated with risk of viral infection, persistence and disease progression. Natural killer (NK) cells are a unique group of lymphocytes involved in surveillance and killing of foreign or infected cells through a mechanism involving recognition of HLA molecules by an extremely diverse set of receptors on the NK cell surface. A major group of these receptors are the KIRs. Thus, a relationship between KIR genotype and HIV infection is biologically plausible, and requires further investigation in observational studies.
The WIHS study is a prospective study, which may allow us to answer questions relating to the role of host HLA and KIR genotype on duration of infection, and the development of virus-associated diseases such as cervical cancer (related to HPV infection), and liver cancer (HBV and HCV). WIHS is a large, racially and geographically diverse cohort of HIV positive (n = 2761), and risk-matched HIV-negative women (n = 942). The large size of the cohort will provide substantial statistical power, which is of major importance in any HLA association study.
- Conditions
- HIV
- Keywords
- Genotyping, HIV, HPV, HCV, HBV
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 start15 Jul 2002
- Study completion18 Aug 2010
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 HIVStudies 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
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339430
- Sponsor's protocol ID
- 999902253
- Other IDs
- 02-C-N253
- Status last verified
- 18 Aug 2010
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Parham P, Ohta T. Population biology of antigen presentation by MHC class I molecules. Science. 1996 Apr 5;272(5258):67-74. doi: 10.1126/science.272.5258.67.
PubMed 8600539Hughes AL, Yeager M. Natural selection at major histocompatibility complex loci of vertebrates. Annu Rev Genet. 1998;32:415-35. doi: 10.1146/annurev.genet.32.1.415.
PubMed 9928486Carrington M, Nelson GW, Martin MP, Kissner T, Vlahov D, Goedert JJ, Kaslow R, Buchbinder S, Hoots K, O'Brien SJ. HLA and HIV-1: heterozygote advantage and B*35-Cw*04 disadvantage. Science. 1999 Mar 12;283(5408):1748-52. doi: 10.1126/science.283.5408.1748.
PubMed 10073943
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women (WIHS)
- ClinicalTrials.gov ID
- NCT00339430
- Acronym / sponsor ID
- 999902253
- Conditions
- HIV
- Keywords
- Genotyping, HIV, HPV, HCV, HBV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 Jul 2002
- Study completion
- 18 Aug 2010
- 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.
Since the beginning of the HIV/AIDS epidemic, the number of women infected with HIV has rapidly increased and is continuing to climb. The Women's Interagency HIV Study is being conducted in several cities in the United States to learn more about how HIV affects women's lives and bodies. It will examine the role of HLA and killer immunoglobulin-like receptors (KIR) in HIV and related infections in HIV-positive and HIV-negative women. The study will determine the relationship between KIR and HLA genes and the following: the risk of HIV infection; HIV levels in the blood; incidence of AIDS; response to highly active antiretroviral therapy (HAART); and response to immunotherapy.
Approximately 3,700 women will participate. Participants will visit the clinic every 6 months for 4 years. An HIV test will be given each time to HIV-negative women. A questionnaire will also be administered. A physical examination and gynecological examination will be given. Blood, vaginal swabs, and urine will be collected for testing. A biological impedance test will determine any changes in weight, waist-to-hip ratios, and breast and total body fat. Low CD4 counts and hospitalizations for HIV are to be self-reported to study staff.
Detailed description
The aim of the study is to examine the role of HLA and killer immunolobulin-like receptors (KIR) in the natural history of HPV, HCV, and HBV in HIV-positive and HIV-negative women. The immune response to viral infection mediated by T lymphocytes is HLA restricted, suggesting that HLA class I, and class II might be associated with risk of viral infection, persistence and disease progression. Natural killer (NK) cells are a unique group of lymphocytes involved in surveillance and killing of foreign or infected cells through a mechanism involving recognition of HLA molecules by an extremely diverse set of receptors on the NK cell surface. A major group of these receptors are the KIRs. Thus, a relationship between KIR genotype and HIV infection is biologically plausible, and requires further investigation in observational studies.
The WIHS study is a prospective study, which may allow us to answer questions relating to the role of host HLA and KIR genotype on duration of infection, and the development of virus-associated diseases such as cervical cancer (related to HPV infection), and liver cancer (HBV and HCV). WIHS is a large, racially and geographically diverse cohort of HIV positive (n = 2761), and risk-matched HIV-negative women (n = 942). The large size of the cohort will provide substantial statistical power, which is of major importance in any HLA association study.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- DNA and relevant clinical data from properly consented WIHS subjects (maximum estimated at 3500) will be provided to our lab for genotyping and analysis.
Key exclusion criteria (1 listed)
- No available subjects will be excluded.
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 2 Jul 2017.
- Background: PubMed 8600539Parham P, Ohta T. Population biology of antigen presentation by MHC class I molecules. Science. 1996 Apr 5;272(5258):67-74. doi: 10.1126/science.272.5258.67.
- Background: PubMed 9928486Hughes AL, Yeager M. Natural selection at major histocompatibility complex loci of vertebrates. Annu Rev Genet. 1998;32:415-35. doi: 10.1146/annurev.genet.32.1.415.
- Background: PubMed 10073943Carrington M, Nelson GW, Martin MP, Kissner T, Vlahov D, Goedert JJ, Kaslow R, Buchbinder S, Hoots K, O'Brien SJ. HLA and HIV-1: heterozygote advantage and B*35-Cw*04 disadvantage. Science. 1999 Mar 12;283(5408):1748-52. doi: 10.1126/science.283.5408.1748.
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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.
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 HIV, 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 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: finished, as of the sponsor's last update on 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339430, 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 2 Jul 2017.