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NCT00025922 · ClinicalTrials.gov registry record
Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 240
- Enrollment target
NCT00025922: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00025922 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00025922 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 240 participants
- Enrollment target
Study Summary
This 2-part study will examine 1) the immune response to influenza (flu) vaccine in HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies have shown that people with HIV infection do not respond as well to flu vaccine as healthy subjects; that is, they don't make as many antibodies in response to the vaccine. Also, studies done before the use of HAART (highly active antiretroviral treatment) have shown that HIV levels increase for a period of time after flu vaccination. One small study showed a small brief increase in HIV even in patients taking HAART. The current trial will examine whether the flu vaccine does, in fact, cause an elevation in viral load and whether this increase is harmful or indicates a better response to the vaccine. HIV-infected patients and healthy normal volunteers between 18 and 60 years of age may be eligible for part1of this study. (Healthy volunteers will serve as control subjects to make sure the flu vaccine stimulates production of enough antibody to protect against the flu). Part 2 will include only HIV-infected patients with fewer than 50 copies per milliliter of HIV. Patients in both parts of the study must have been receiving HAART (consisting of at least two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor) for at least 3 months before enrollment in the study. Candidates will be screened with a medical history and blood tests, including HLA testing (a genetic test of immune system markers). 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: * Part 1 - Immune Response to Flu Vaccine In the first of two visits, participants will have blood drawn for flu antibody levels before vaccination and, in HIV-infected patients, measures of T cell count and viral load. They will then receive the flu vaccine. Blood will be draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2001-10 |
| Est. Completion | 2003-10 |
What the finished NCT00025922 record still lists
NCT00025922 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00025922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00025922 about?
NCT00025922 is a clinical study titled "Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load". This 2-part study will examine 1) the immune response to influenza (flu) vaccine in HIV-infected patients, and 2) the effect of flu vaccine on HIV viral loads. Earlier studies have shown that people with HIV infection do not respond as well to flu vaccine as healthy subjects; that is, they don't mak...
What is the current status of trial NCT00025922?
This trial is currently completed. The enrollment target is 240 participants. The study started on 2001-10. Estimated completion is 2003-10.
Who is sponsoring clinical trial NCT00025922?
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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