- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00067795
Evaluating Immune Function Tests in People With HIV
HIV Antigen-Specific Immune Responses - A Comparison of Alternative In Vitro Assays From Subjects Characterized as Either "Stable HAART" or "Efficient Immune Control"
Study Overview
Status
Conditions
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 Type
Enrollment
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35924-2050
- University of Alabama at Birmingham
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California
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Sacremento, California, United States, 95814
- UC Davis Medical Center
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Florida
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Miami, Florida, United States, 33136-1013
- University of Miami
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Illinois
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Chicago, Illinois, United States, 60612-3806
- Rush-Presbyterian/St. Lukes
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Ohio
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Cleveland, Ohio, United States, 44106-5083
- Case Western Reserve University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213-2582
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Cohorts A and B:
- 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
Inclusion Criteria for Cohort A (Stable HAART) Only:
- 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
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Study Chair: R. Pat Bucy, MD, PhD, University of Alabama at Birmingham
Publications and helpful links
General 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.
- Bucy 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.
- Pantaleo 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.
- Macatangay 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.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG A5181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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