HealthyNCT00027482
Immune Responses to HIV in Blood Cells in HIV-Infected and HIV-Uninfected Volunteers
An observational study of Healthy and HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time. Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, HIV Infection
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2001to 27 Aug 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to be tested for HIV.
- Note: Subjects known to be HIV-infected will routinely have results of plasma HIV RNA obtained at or within 90 days of the enrollment visit recorded; volunteers believed to be HIV uninfected will usually have HIV ELISA (Western blot if needed) and/or HIV RNA within 28 days of the enrollment visit recorded. Test results do not have to be available before proceeding with enrollment. Consent to be tested is required, but the testing itself does not have to be completed if not needed by the research lab as subjects are eligible regardless of HIV status.
- Age: 18 years of age or older.
- Ability to provide informed consent
Who cannot join
- Refusal to consent to follow study site policy on partner notification (if newly diagnosed as HIV-positive while participating in this study).
- Refusal to permit research specimens to be stored (frozen) for potential future studies.
- Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as coagulopathy or inadequate venous access).
- Women known to be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Studies of Specific Immune Responses in HIV-Infected and HIV-Uninfected Volunteers
This study will explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time.
Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study.
Read more
Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A medical history will be obtained if relevant to the laboratory research for which the sample will be used. A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician. A complete blood count will be performed on the day of enrollment and yearly thereafter. Samples will be collected in the following manner:
Blood will be drawn from a needle in an arm vein one or more times during the course of the study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period.
Urine and saliva samples will be collected by the volunteer in private.
Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the mouth.
Samples may be used for the following tests:
- Hepatitis and other viral screening-This may include screening for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus (related to the herpes virus); and for varicella zoster virus (responsible for chicken pox in children and shingles in adults).
- Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or chemical changes) or deletions (missing pieces) that affect substances involved in the body's ability to mount an inflammatory immune response. Alterations in the genes for some of these substances have been shown to influence HIV infection.
- HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is necessary in order to do certain research studies. Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems. HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions.
- Other laboratory tests as clinically indicated or required for research needs.
Some samples collected in this study may be stored for future research.They will be labeled without identifying information.
Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions.
Read the detailed description
The Vaccine Research Center (VRC) is studying specific immune responses to HIV infection and other pathogens in order to characterize protective responses that can prevent new infection in uninfected individuals, as well as define those responses that lead to successful control of viral replication in persons already infected with the pathogen. We wish to define the specific human immune responses to HIV infection, other pathogens and vaccines using human peripheral blood mononuclear cells, plasma, serum, urine, or oral secretions as a model.
- Conditions
- Healthy, HIV Infection
- Keywords
- T Cell, B Cell, Flow Cytometry, Cell-Mediated Immunity, Thymus, HIV, Immunity, Lymphocytes, Monocytes, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2001 (estimated)
- Study start4 Dec 2001
- Study completion27 Aug 2008
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 HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- 2,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027482
- Sponsor's protocol ID
- 020066
- Other IDs
- 02-I-0066
- Status last verified
- 27 Aug 2008
- First submitted
- 7 Dec 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Betts MR, Casazza JP, Patterson BA, Waldrop S, Trigona W, Fu TM, Kern F, Picker LJ, Koup RA. Putative immunodominant human immunodeficiency virus-specific CD8(+) T-cell responses cannot be predicted by major histocompatibility complex class I haplotype. J Virol. 2000 Oct;74(19):9144-51. doi: 10.1128/jvi.74.19.9144-9151.2000.
PubMed 10982361Allen TM, O'Connor DH, Jing P, Dzuris JL, Mothe BR, Vogel TU, Dunphy E, Liebl ME, Emerson C, Wilson N, Kunstman KJ, Wang X, Allison DB, Hughes AL, Desrosiers RC, Altman JD, Wolinsky SM, Sette A, Watkins DI. Tat-specific cytotoxic T lymphocytes select for SIV escape variants during resolution of primary viraemia. Nature. 2000 Sep 21;407(6802):386-90. doi: 10.1038/35030124.
PubMed 11014195Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
PubMed 8207839
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
- Studies of Specific Immune Responses in HIV-Infected and HIV-Uninfected Volunteers
- ClinicalTrials.gov ID
- NCT00027482
- Acronym / sponsor ID
- 020066
- Conditions
- Healthy, HIV Infection
- Keywords
- T Cell, B Cell, Flow Cytometry, Cell-Mediated Immunity, Thymus, HIV, Immunity, Lymphocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 4 Dec 2001
- Study completion
- 27 Aug 2008
- First posted
- 7 Dec 2001 (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 explore the responses of the immune system to infection with HIV and other pathogens and the changes in these responses over time.
Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study.
Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded. A medical history will be obtained if relevant to the laboratory research for which the sample will be used. A more extensive history and physical exam is not required but may be performed if deemed necessary by the VRC clinician. A complete blood count will be performed on the day of enrollment and yearly thereafter. Samples will be collected in the following manner:
Blood will be drawn from a needle in an arm vein one or more times during the course of the study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period.
Urine and saliva samples will be collected by the volunteer in private.
Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the mouth.
Samples may be used for the following tests:
- Hepatitis and other viral screening-This may include screening for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus (related to the herpes virus); and for varicella zoster virus (responsible for chicken pox in children and shingles in adults).
- Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or chemical changes) or deletions (missing pieces) that affect substances involved in the body's ability to mount an inflammatory immune response. Alterations in the genes for some of these substances have been shown to influence HIV infection.
- HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is necessary in order to do certain research studies. Some HLA types have been associated with an increased risk of diseases like arthritis and other rheumatologic problems. HLA testing may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions.
- Other laboratory tests as clinically indicated or required for research needs.
Some samples collected in this study may be stored for future research.They will be labeled without identifying information.
Those with interesting or strongly positive immune responses may be asked to return to the VRC Clinic to provide samples of urine or oral secretions.
Detailed description
The Vaccine Research Center (VRC) is studying specific immune responses to HIV infection and other pathogens in order to characterize protective responses that can prevent new infection in uninfected individuals, as well as define those responses that lead to successful control of viral replication in persons already infected with the pathogen. We wish to define the specific human immune responses to HIV infection, other pathogens and vaccines using human peripheral blood mononuclear cells, plasma, serum, urine, or oral secretions as a model.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Note: Subjects known to be HIV-infected will routinely have results of plasma HIV RNA obtained at or within 90 days of the enrollment visit recorded; volunteers believed to be HIV uninfected will usually have HIV ELISA (Western blot if needed) and/or HIV RNA within 28 days of the enrollment visit recorded. Test results do not have to be available before proceeding with enrollment. Consent to be tested is required, but the testing itself does not have to be completed if not needed by the research lab as subjects are eligible regardless of HIV status.
Key exclusion criteria (4 listed)
- Refusal to consent to follow study site policy on partner notification (if newly diagnosed as HIV-positive while participating in this study).
- Refusal to permit research specimens to be stored (frozen) for potential future studies.
- Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as coagulopathy or inadequate venous access).
- Women known to be pregnant
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 10982361Betts MR, Casazza JP, Patterson BA, Waldrop S, Trigona W, Fu TM, Kern F, Picker LJ, Koup RA. Putative immunodominant human immunodeficiency virus-specific CD8(+) T-cell responses cannot be predicted by major histocompatibility complex class I haplotype. J Virol. 2000 Oct;74(19):9144-51. doi: 10.1128/jvi.74.19.9144-9151.2000.
- Background: PubMed 11014195Allen TM, O'Connor DH, Jing P, Dzuris JL, Mothe BR, Vogel TU, Dunphy E, Liebl ME, Emerson C, Wilson N, Kunstman KJ, Wang X, Allison DB, Hughes AL, Desrosiers RC, Altman JD, Wolinsky SM, Sette A, Watkins DI. Tat-specific cytotoxic T lymphocytes select for SIV escape variants during resolution of primary viraemia. Nature. 2000 Sep 21;407(6802):386-90. doi: 10.1038/35030124.
- Background: PubMed 8207839Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
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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 Healthy and HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 4 inclusion and 4 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 NCT00027482, 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.