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Evaluating Immune Function Tests in People With HIV
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00067795
  Purpose

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.


Condition
HIV Infections

MedlinePlus related topics: AIDS AIDS Medicines
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
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"

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 54
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067795

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35924-2050
United States, California
UC Davis Medical Center
Sacremento, California, United States, 95814
United States, Florida
University of Miami
Miami, Florida, United States, 33136-1013
United States, Illinois
Rush-Presbyterian/St. Lukes
Chicago, Illinois, United States, 60612-3806
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106-5083
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2582
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2582
Sponsors and Collaborators
Investigators
Study Chair: R. Pat Bucy, MD, PhD University of Alabama at Birmingham
  More Information

Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG A5181
Study First Received: August 27, 2003
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00067795  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Antiretroviral Therapy, Highly Active
HIV Antigens
Cohort Studies
Immunity, Cellular
T-Lymphocytes

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009