Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067795
Status:
COMPLETED
Last Update Posted:
2010-11-22
First Post:
2003-08-27
Brief Title:
Evaluating Immune Function Tests in People With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some peoples 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 copiesml 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 3000 copiesml Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24 Blood samples will be used for CD4CD8 cell count plasma HIV-1 RNA and immunologic assays
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 3000 copiesml Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24 Blood samples will be used for CD4CD8 cell count plasma HIV-1 RNA and immunologic assays
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None