Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342160
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2006-06-19
Brief Title:
Viral and Immunologic Factors Contributing to the Lack of HIV Transmission Among Couples in Rakai Uganda
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Virologic and Immunologic Factors Contributing to the Lack of HIV-1 Transmission in HIV-Discordant Couples in Rakai Uganda
Status:
COMPLETED
Status Verified Date:
2012-11-13
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:
This study will look at viral and immunologic factors involved in protecting against sexually transmitted HIV infection in couples in which one partner is infected and the other is not
This study will include 50 couples who reside in Rakai Uganda and who have been together for at least 2 years In some couples both partners will be HIV-infected in some couples only one partner will have HIV and in some couples neither partner will have HIV
Participants undergo the following procedures at each of four study visits
HIV counseling and testing
Medical history including questions about personal behaviors such as sexual practices and use of condoms
Blood sample collection
Urine sample collection
Vaginal swab for women
Blood urine and vaginal fluid samples are tested for HIV and other sexually transmitted diseases such as syphilis Blood and vaginal samples are also tested for HIV viral levels and immune response in HIV-infected individuals and for evidence of exposure to HIV in non-infected participants Some blood is also tested for genetic markers to investigate whether certain proteins are related to resistance to HIV infection
This study will include 50 couples who reside in Rakai Uganda and who have been together for at least 2 years In some couples both partners will be HIV-infected in some couples only one partner will have HIV and in some couples neither partner will have HIV
Participants undergo the following procedures at each of four study visits
HIV counseling and testing
Medical history including questions about personal behaviors such as sexual practices and use of condoms
Blood sample collection
Urine sample collection
Vaginal swab for women
Blood urine and vaginal fluid samples are tested for HIV and other sexually transmitted diseases such as syphilis Blood and vaginal samples are also tested for HIV viral levels and immune response in HIV-infected individuals and for evidence of exposure to HIV in non-infected participants Some blood is also tested for genetic markers to investigate whether certain proteins are related to resistance to HIV infection
Detailed Description:
Understanding the factors that contribute to the transmission of human immunodeficiency virus HIV infection is of great importance for the development of preventive and therapeutic strategies Evidence suggests that a number of host immunologic and virologic factors play critical roles in protection against sexually transmitted HIV infection in HIV-discordant partners Among these the antiviral role of CD8 T cells in HIV-infected individuals has been extensively studied At least two types of CD8 T cell-mediated antiviral activities have been described in HIV infection The first is a suppressive activity against HIV involving lysis of infected cells in an antigen-specific HLA-restricted fashion while the second mechanism inhibits viral replication via either cell- or soluble mediated factors in the absence of cell killing It has been demonstrated that cytotoxic CD8 T lymphocytes CTL are present in both cervical and peripheral blood mononuclear cells PBMC from a subpopulation of highly-HIV-exposed but persistently seronegative individuals However studies addressing the effect of non-cytotoxic soluble factor-mediated antiviral activity by CD8 T cells in preventing seroconversion in HIV-discordant couples have been lacking This study proposes to examine the role of CD8 T cell-derived CC-chemokine activities and the copy numbers of one of the chemokine genes CCL3L1 along with other host anti-HIV and virologic factors in resistance to HIV infection in persistently seronegative HIV-discordant partners of HIV infected individuals
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 |
|---|---|---|---|
| 06-I-N100 | None | None | None |