Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029913
Status:
COMPLETED
Last Update Posted:
2010-09-02
First Post:
2002-01-24
Brief Title:
A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
Sponsor:
HIV Vaccine Trials Network
Organization:
HIV Vaccine Trials Network
Study Overview
Official Title:
A Multi-Site Evaluation of Virologic Immunologic and Clinical Natural History of Participants Enrolled in Phase I and Phase II HIV-1 Vaccine Protocols or HIV-1 Vaccine Preparedness Cohorts Who Develop HIV-1 Infection Subsequent to Trial Enrollment
Status:
COMPLETED
Status Verified Date:
2010-08
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:
Despite risk reduction counseling some individuals in HIV vaccine trials or vaccine preparedness studies may engage in risk behavior that results in HIV infection The purpose of the HVTN 403 study is to find out more about how persons respond to HIV infection if they have received an experimental HIV-1 vaccine before they became HIV infected
Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical trial before getting infected with HIV Other people in this study were in a vaccine preparedness study when they got infected with HIV None of these individuals became infected with HIV as result of their participation in an HIV vaccine or vaccine preparedness study HVTN 403 will compare immune responses between those who previously received an experimental HIV vaccine and those who did not Information learned from this study may be important in guiding future developments of new HIV vaccines and other treatments for HIV and AIDS
Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical trial before getting infected with HIV Other people in this study were in a vaccine preparedness study when they got infected with HIV None of these individuals became infected with HIV as result of their participation in an HIV vaccine or vaccine preparedness study HVTN 403 will compare immune responses between those who previously received an experimental HIV vaccine and those who did not Information learned from this study may be important in guiding future developments of new HIV vaccines and other treatments for HIV and AIDS
Detailed Description:
It is important to study persons vaccinated with candidate HIV-1 vaccines who have become HIV-1 infected for the following reasons First if transient HIV-1 infection is detected and then is effectively suppressed or cleared it will be important to document the antigenic relationship between the breakthrough virus and the vaccine epitopes to attempt to answer questions about the specificity and breadth of the immune response and the determinants of immunity A second reason is to gain a better understanding of vaccine-induced responses in those participants who are transiently or persistently HIV-1-infected compared to placebo recipients who become HIV-1-infected If the vaccine does not prevent HIV-1 infection it will be important to characterize the course of the disease as measured by longitudinal viral load measurements CD4 counts and clinical symptoms Understanding the breadth magnitude and specificity of the immune response in partially or fully immunized vaccinees after infection and the impact on clinical symptoms and disease progression can potentially result in valuable information for the subsequent design of vaccine efficacy trials and ultimately in consideration of potential effectiveness of HIV-1 vaccines
Study visits occur at Days 0 7 14 28 then at 2 months 3 months 6 months and every 6 months thereafter At these visits patients are given a physical exam blood is drawn and a donation of genital fluids is requested at certain visits Patients are asked to donate samples of either semen men or cervical secretions women viral load is measured and compared to the amount and types of virus in the blood Heshe may refuse to donate these genital fluids and still be eligible to remain in the study Primary medical care or medications for HIV infection are not provided by this study
Study visits occur at Days 0 7 14 28 then at 2 months 3 months 6 months and every 6 months thereafter At these visits patients are given a physical exam blood is drawn and a donation of genital fluids is requested at certain visits Patients are asked to donate samples of either semen men or cervical secretions women viral load is measured and compared to the amount and types of virus in the blood Heshe may refuse to donate these genital fluids and still be eligible to remain in the study Primary medical care or medications for HIV infection are not provided by this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01AI068614 | NIH | None | httpsreporternihgovquickSearch5U01AI068614 |