HIV InfectionsNCT00067795
Evaluating Immune Function Tests in People With HIV
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other people with HIV must take drugs to prevent the virus from destroying their immune systems. There are many different laboratory tests that measure immune function in people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 54 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- CD4 cell count > 300 cells/mm3 within 60 days prior to study entry
- Negative pregnancy test within 14 days of starting study
- Agree to use acceptable methods of contraception while in study
- Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
- Viral load < 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry
Show all 10Show fewer
- No single viral load >= 75 copies/ml within 9 months prior to study entry
- Inclusion Criteria for Cohort B (Efficient Immune Control) Only:
- Not taking any antiretroviral drugs for at least 6 months prior to study entry
- Meets study definition of efficient immune control (generally HIV-1 viral load < 3,000 copies/ml, with some exceptions)
Who cannot join
- Pregnancy or breast-feeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of an AIDS-defining opportunistic infection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35924-2050
Rush-Presbyterian/St. Lukes
Chicago, Illinois, 60612-3806
Case Western Reserve University
Cleveland, Ohio, 44106-5083
University of Miami
Miami, Florida, 33136-1013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582
UC Davis Medical Center
Sacremento, California, 95814
About this study
Official title: HIV Antigen-Specific Immune Responses - A Comparison of Alternative In Vitro Assays From Subjects Characterized as Either "Stable HAART" or "Efficient Immune Control"
Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other people with HIV must take drugs to prevent the virus from destroying their immune systems. There are many different laboratory tests that measure immune function in people with HIV. This study will compare some of these tests to see if they consistently measure differences between people who control the HIV without anti-HIV drugs and those who must take drugs.
Read the detailed description
The efficiency of the immune response to HIV antigens is the critical feature that allows some individuals with chronic HIV infection to maintain low level viremia (less than 3000 copies/ml). The fundamental measurement of this response is the steady state level of viremia in the absence of antiretroviral drugs. However, using this clinical endpoint in vaccine and drug trials is time-consuming. Several laboratory assays of HIV T cell function have been developed to measure the key characteristics of an efficient immune response. This study will evaluate these assays in two distinct patient populations.
Two patient cohorts will be followed in this study. Cohort A will enroll patients who are stable on highly active antiretroviral therapy (HAART). These patients will have been on the same HAART regimen for at least 9 months prior to study entry. Cohort B will enroll patients with chronic HIV infection and efficient immune control. These patients will have not been on any antiretroviral drugs for at least 6 months and will have viral loads less than 3,000 copies/ml. Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24. Blood samples will be used for CD4/CD8 cell count, plasma HIV-1 RNA, and immunologic assays.
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Antiretroviral Therapy, Highly Active, HIV Antigens, Cohort Studies, Immunity, Cellular, T-Lymphocytes
- 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 posted28 Aug 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Time perspective
- Prospective
- Enrolment
- 54 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- R. Pat Bucy, MD, PhD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067795
- Sponsor's protocol ID
- ACTG A5181
- Status last verified
- Nov 2010
- First submitted
- 27 Aug 2003
- Last updated
- 22 Nov 2010
- Results posted
- No
Publications
Bucy RP, Kilby JM. Perspectives on inducing efficient immune control of HIV-1 replication--a new goal for HIV therapeutics? AIDS. 2001 Feb;15 Suppl 2:S36-42. doi: 10.1097/00002030-200102002-00007.
PubMed 11424975Bucy RP. Immune clearance of HIV type 1 replication-active cells: a model of two patterns of steady state HIV infection. AIDS Res Hum Retroviruses. 1999 Feb 10;15(3):223-7. doi: 10.1089/088922299311394. No abstract available.
PubMed 10052752Pantaleo G, Menzo S, Vaccarezza M, Graziosi C, Cohen OJ, Demarest JF, Montefiori D, Orenstein JM, Fox C, Schrager LK, et al. Studies in subjects with long-term nonprogressive human immunodeficiency virus infection. N Engl J Med. 1995 Jan 26;332(4):209-16. doi: 10.1056/NEJM199501263320402.
PubMed 7808486Macatangay BJ, Zheng L, Rinaldo CR, Landay AL, Pollard RB, Pahwa S, Lederman MM, Bucy RP. Comparison of immunologic assays for detecting immune responses in HIV immunotherapeutic studies: AIDS Clinical Trials Group Trial A5181. Clin Vaccine Immunol. 2010 Sep;17(9):1452-9. doi: 10.1128/CVI.00498-09. Epub 2010 Jul 14.
PubMed 20631337
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Antigen-Specific Immune Responses - A Comparison of Alternative In Vitro Assays From Subjects Characterized as Either "Stable HAART" or "Efficient Immune Control"
- ClinicalTrials.gov ID
- NCT00067795
- Acronym / sponsor ID
- ACTG A5181
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Antiretroviral Therapy, Highly Active, HIV Antigens, Cohort Studies, Immunity, Cellular, T-Lymphocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 28 Aug 2003 (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.
Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other people with HIV must take drugs to prevent the virus from destroying their immune systems. There are many different laboratory tests that measure immune function in people with HIV. This study will compare some of these tests to see if they consistently measure differences between people who control the HIV without anti-HIV drugs and those who must take drugs.
Detailed description
The efficiency of the immune response to HIV antigens is the critical feature that allows some individuals with chronic HIV infection to maintain low level viremia (less than 3000 copies/ml). The fundamental measurement of this response is the steady state level of viremia in the absence of antiretroviral drugs. However, using this clinical endpoint in vaccine and drug trials is time-consuming. Several laboratory assays of HIV T cell function have been developed to measure the key characteristics of an efficient immune response. This study will evaluate these assays in two distinct patient populations.
Two patient cohorts will be followed in this study. Cohort A will enroll patients who are stable on highly active antiretroviral therapy (HAART). These patients will have been on the same HAART regimen for at least 9 months prior to study entry. Cohort B will enroll patients with chronic HIV infection and efficient immune control. These patients will have not been on any antiretroviral drugs for at least 6 months and will have viral loads less than 3,000 copies/ml. Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24. Blood samples will be used for CD4/CD8 cell count, plasma HIV-1 RNA, and immunologic assays.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV-1 infection
- CD4 cell count > 300 cells/mm3 within 60 days prior to study entry
- Negative pregnancy test within 14 days of starting study
- Agree to use acceptable methods of contraception while in study
- Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
Key exclusion criteria (3 listed)
- Pregnancy or breast-feeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of an AIDS-defining opportunistic infection
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 22 Nov 2010.
- Background: PubMed 11424975Bucy RP, Kilby JM. Perspectives on inducing efficient immune control of HIV-1 replication--a new goal for HIV therapeutics? AIDS. 2001 Feb;15 Suppl 2:S36-42. doi: 10.1097/00002030-200102002-00007.
- Background: PubMed 10052752Bucy RP. Immune clearance of HIV type 1 replication-active cells: a model of two patterns of steady state HIV infection. AIDS Res Hum Retroviruses. 1999 Feb 10;15(3):223-7. doi: 10.1089/088922299311394. No abstract available.
- Background: PubMed 7808486Pantaleo G, Menzo S, Vaccarezza M, Graziosi C, Cohen OJ, Demarest JF, Montefiori D, Orenstein JM, Fox C, Schrager LK, et al. Studies in subjects with long-term nonprogressive human immunodeficiency virus infection. N Engl J Med. 1995 Jan 26;332(4):209-16. doi: 10.1056/NEJM199501263320402.
- Results publication: PubMed 20631337Macatangay BJ, Zheng L, Rinaldo CR, Landay AL, Pollard RB, Pahwa S, Lederman MM, Bucy RP. Comparison of immunologic assays for detecting immune responses in HIV immunotherapeutic studies: AIDS Clinical Trials Group Trial A5181. Clin Vaccine Immunol. 2010 Sep;17(9):1452-9. doi: 10.1128/CVI.00498-09. Epub 2010 Jul 14.
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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.
R. Pat Bucy, MD, PhD study chair
University of Alabama at Birmingham
6 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 Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 10 inclusion and 3 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 22 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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 NCT00067795, which also lists 4 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 22 Nov 2010; AzTrials last refreshed its copy on 28 Oct 2026.