Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001121
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
1999-11-02
Brief Title:
A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Virologic Immunologic and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1
Status:
COMPLETED
Status Verified Date:
2003-06
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:
The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known but discouraged high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014 Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS
Patients who receive HIV vaccines are sometimes protected from HIV infection More often these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS
Patients who receive HIV vaccines are sometimes protected from HIV infection More often these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS
Detailed Description:
There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines In the best-case scenario these vaccines may prevent infection sterilizing immunity However current viral vaccines are thought to limit but not prevent virus replication after infection In the latter case it is important to document the effect of the immune response on the disease course as reflected by viral load the evolution of the viral quasi species and clinical symptoms over time Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter Additionally HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment and may be asked to donate additional specimens at a later time Study endpoints include various virologic immunologic and clinical parameters such as viral load cellular immune response and virus phenotype and genotype
Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter Additionally HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment and may be asked to donate additional specimens at a later time Study endpoints include various virologic immunologic and clinical parameters such as viral load cellular immune response and virus phenotype and genotype
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