Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351442
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2006-07-11
Brief Title:
Examining Factors That May Influence Resistance to HIV-1 Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prospective Study of the Determinants of Host Resistance to HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2014-04
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 people who are exposed to the HIV-1 virus are capable of either controlling or completely preventing viral infection Multiple genetic factors may contribute to preventing or controlling HIV-1 infection The purpose of this study is to analyze the immune system responses of individuals who are exposed to HIV-1 but remain uninfected
Detailed Description:
Even with repeated exposure to HIV-1 some individuals appear to be resistant to infection The exact mechanism of this resistance however remains unknown The relative risk of HIV-1 infection appears to depend on various factors route of transmission viral load of the infected donor nature and extent of exposure presence of sexually transmitted infections STIs and genetic and immunological status of the exposed individual This last factor may explain the inherent ability of some people to remain uninfected despite repeated exposure to HIV-1
Immune response in HIV-1 exposed uninfected individuals is sometimes characterized by specific cytotoxic CD8 T cell response without antibody response suggesting that resistance may in part be mediated by HIV-1 specific T cells Exposed uninfected individuals may also be genetically protected in which case key genes-possibly linked to immune responses-may lead to resistance to HIV-1 A clearer understanding of the role of an individuals genetic and immune-mediated resistance to HIV-1 infection is needed and will provide important information for advancing preventive HIV vaccine design The purpose of this study is to examine the immune responses of individuals who have been exposed to HIV-1 but who remain uninfected Through the use of highly sensitive technology low level immune responses and viral levels will be evaluated The study will also compare genetic profiles exposure characteristics donor viral load STIs and sexual behaviors among all participants In the infected member of a serodiscordant couple the HIV-1 virus will be examined and sequenced
This observational study will last approximately 24 months Screening will involve at least one visit and will occur at least 8 weeks prior to study entry Eligible participants will fall into one of three groups
Group 1 will include individuals who have been exposed to HIV-1 but who remain uninfected
Group 2 will include HIV infected regular sexual partners of Group 1 members
Group 3 will include HIV uninfected individuals or couples who have not been exposed to HIV-1
Study visits will occur every 3 months for a total of 8 visits At all visits participants will verify address location complete standardized questionnaires about sexual behaviors and receive HIV safe sex counseling and free condoms Blood and urine will be collected to test for HIV STIs and pregnancy All participants will undergo a review of their medical history and a physical examination including a genital exam for both males and females and a pelvic exam for females At selected visits participants may opt to provide additional samples of urine saliva genital secretions breastmilk and feces for research purposes Groups 1 and 3 will have HIV testing at all but the first study visit Group 2 will have no HIV testing but will be assessed for CD4 cell count at all study visits Participants requiring clinical care for the management of HIV or STIs will be either treated at the study site or referred for appropriate care
Immune response in HIV-1 exposed uninfected individuals is sometimes characterized by specific cytotoxic CD8 T cell response without antibody response suggesting that resistance may in part be mediated by HIV-1 specific T cells Exposed uninfected individuals may also be genetically protected in which case key genes-possibly linked to immune responses-may lead to resistance to HIV-1 A clearer understanding of the role of an individuals genetic and immune-mediated resistance to HIV-1 infection is needed and will provide important information for advancing preventive HIV vaccine design The purpose of this study is to examine the immune responses of individuals who have been exposed to HIV-1 but who remain uninfected Through the use of highly sensitive technology low level immune responses and viral levels will be evaluated The study will also compare genetic profiles exposure characteristics donor viral load STIs and sexual behaviors among all participants In the infected member of a serodiscordant couple the HIV-1 virus will be examined and sequenced
This observational study will last approximately 24 months Screening will involve at least one visit and will occur at least 8 weeks prior to study entry Eligible participants will fall into one of three groups
Group 1 will include individuals who have been exposed to HIV-1 but who remain uninfected
Group 2 will include HIV infected regular sexual partners of Group 1 members
Group 3 will include HIV uninfected individuals or couples who have not been exposed to HIV-1
Study visits will occur every 3 months for a total of 8 visits At all visits participants will verify address location complete standardized questionnaires about sexual behaviors and receive HIV safe sex counseling and free condoms Blood and urine will be collected to test for HIV STIs and pregnancy All participants will undergo a review of their medical history and a physical examination including a genital exam for both males and females and a pelvic exam for females At selected visits participants may opt to provide additional samples of urine saliva genital secretions breastmilk and feces for research purposes Groups 1 and 3 will have HIV testing at all but the first study visit Group 2 will have no HIV testing but will be assessed for CD4 cell count at all study visits Participants requiring clinical care for the management of HIV or STIs will be either treated at the study site or referred for appropriate care
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 |
|---|---|---|---|
| 10464 | REGISTRY | DAIDS-ES | None |