Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02333045
Status:
TERMINATED
Last Update Posted:
2018-01-19
First Post:
2015-01-05
Brief Title:
Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Minimal efficacy of maraviroc alone was found in preliminary data analysis of another study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIP
Brief Summary:
This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc a medicine used in the treatment of HIV infection
Detailed Description:
In this study the investigator seeks to understand the immune cells in the cervical fluid of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc a medicine used in the treatment of HIV infection Maraviroc works by preventing HIV from entering human immune cells by blocking a protein on the outside of these cells called the C-C chemokine receptor type 5 CCR5 receptor When maraviroc is bound to this protein the virus cannot enter the cell The investigator thinks that CCR5 antagonists could be particularly good drugs for HIV pre-exposure prophylaxis PrEP and could potentially be dosed in ways that are easier to take than the current drugs used for PrEP
In order to further evaluate this PrEP strategy the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age menstrual cycle and genital infections
The amount of maraviroc compared with the drugs in the current drugs used for PrEP tenofovir emtricitabine in the blood and genital tract of HIV-negative healthy female volunteers before during and after they are given maraviroc versus tenofovir emtricitabine for 7 days will be measured We will also study immune cells from the blood and genital tract from these women to see if maraviroc tenofovir or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV
In order to further evaluate this PrEP strategy the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age menstrual cycle and genital infections
The amount of maraviroc compared with the drugs in the current drugs used for PrEP tenofovir emtricitabine in the blood and genital tract of HIV-negative healthy female volunteers before during and after they are given maraviroc versus tenofovir emtricitabine for 7 days will be measured We will also study immune cells from the blood and genital tract from these women to see if maraviroc tenofovir or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV
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