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Evaluating Immune Function Tests in People With HIV

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00067795
First received: August 27, 2003
Last updated: November 19, 2010
Last verified: November 2010
  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

Study Type: Observational
Study Design: Time Perspective: 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"

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Investigators
Study Chair: R. Pat Bucy, MD, PhD University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00067795     History of Changes
Other Study ID Numbers: ACTG A5181
Study First Received: August 27, 2003
Last Updated: November 19, 2010
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014