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NCT00069914 · ClinicalTrials.gov registry record
Immune Response to Influenza Vaccine in HIV-Infected Individuals
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 165
- Enrollment target
NCT00069914 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 165 participants.
The verdict
NCT00069914 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 165 participants
- Enrollment target
Study Summary
This study will evaluate how HIV infection, including CD4 cell count and viral load, affects the patient's ability to produce antibodies in response to vaccination with the influenza (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects to flu vaccine; that is, they don't make as many antibodies in response to the vaccine. Before the use of current anti-HIV medications, antibodies made to flu vaccination in HIV-positive individuals was related to their CD4 cell count. This trial will examine how CD4 counts and the amount of virus in the blood affect how much and what kind of antibodies the body makes to the flu vaccine. HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Healthy subjects will serve as controls to make sure the flu vaccine works (i.e., stimulates production of enough antibody to protect against the flu), and to compare the amount of antibodies made by HIV-positive and HIV-negative people. Candidates will be screened with a medical history and blood tests (see below). Women who are able to have children will have a pregnancy test. Pregnant women are excluded from the study. Participants will undergo the following procedures: 1. Blood drawing for the following tests: * Routine tests (complete blood count, kidney and liver functions, electrolyte levels). * CD4 cell count. * HLA typing (a genetic marker of the immune system) if it has not already been done at the NIH. This test may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. Determining HLA type is necessary to be able to perform certain research studies. Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems. * Viral load (HIV-infected patients only). * Influenza antibody levels. * B cell levels. 2. Flu vaccination 3. Fo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2003-09 |
| Est. Completion | 2005-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069914
The ClinicalTrials.gov registry entry for NCT00069914 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00069914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069914 about?
NCT00069914 is a clinical study titled "Immune Response to Influenza Vaccine in HIV-Infected Individuals". This study will evaluate how HIV infection, including CD4 cell count and viral load, affects the patient's ability to produce antibodies in response to vaccination with the influenza (flu) vaccine. Earlier studies have shown that people with HIV infection do not respond as well as healthy subjects t...
What is the current status of trial NCT00069914?
This trial is currently completed. The enrollment target is 165 participants. The study started on 2003-09. Estimated completion is 2005-09.
Who is sponsoring clinical trial NCT00069914?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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