Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01749566
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2012-11-09
Brief Title:
Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women
Status:
COMPLETED
Status Verified Date:
2015-07
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:
MVC-PREP
Brief Summary:
Pre-exposure prophylaxis PrEP is an HIV prevention strategy in which HIV medicines are used by a person before they are exposed to HIV in order to decrease his or her chance of getting infected In this study we will investigate a new PrEP strategy in women using a drug called maraviroc a medicine used in the treatment of HIV infection called a CCR5 antagonist We hypothesize that maraviroc could be a particularly good drug for PrEP because it achieves high concentrations in the genital tract in women and decreases the number of HIV-susceptible cells in the genital tract and thus could potentially be dosed in more favorable ways than the current PrEP drugs
In order to further evaluate this PrEP strategy we plan to measure the amount of maraviroc in the blood and genital tract of HIV-negative healthy female volunteers before during and after they are given maraviroc dosed either in the standard twice a day or reduced once a day dose for 7 days compared with women who are not given maraviroc We will also study immune cells from the blood and genital tract from these women to see if maravoric has an effect on these cells that would prevent them from becoming infected with HIV
In order to further evaluate this PrEP strategy we plan to measure the amount of maraviroc in the blood and genital tract of HIV-negative healthy female volunteers before during and after they are given maraviroc dosed either in the standard twice a day or reduced once a day dose for 7 days compared with women who are not given maraviroc We will also study immune cells from the blood and genital tract from these women to see if maravoric has an effect on these cells that would prevent them from becoming infected with HIV
Detailed Description:
RATIONALE Globally over half of HIV-infected adults are women and in the United States 25 of all HIVAIDS cases occur in women Women often lack control over many available prevention measures underscoring a critical need to enhance HIV prevention options for women Pre-exposure prophylaxis PrEP is an HIV prevention strategy in which antiretroviral ARV drugs are used prior to potential HIV exposure to reduce the likelihood of infection This strategy which usually contains the drug tenofovir disoproxil fumarate TDF has recently shown promise but efficacy data suggest room for improvement particularly for women in whom these data are conflicting This study aims to prospectively examine ARV pharmacology and mucosal immunology in order to evaluate a novel PrEP strategy in women - blockade of HIV entry from its target cells at the mucosal surface using the CCR5 receptor antagonist maraviroc MVC These actions of CCR5 receptor antagonism if validated could lead to reduced HIV acquisition risk at more favorable dosing strategies than available for current PrEP Knowledge of pharmacological modulation of mucosal immunity and HIV acquisition risk is fundamental to understanding improving and designing new PrEP strategies
DESIGN This is a prospective observational cohort study with an intensive pharmacokinetic component conducted in HIV-negative healthy women Genital tract and whole blood samples will be collected before during and after treatment with 7 days of oral MVC dosed at 300mg twice daily standard or 300mg daily reduced compared with no treatment control Genital tract and plasma MVC concentration will be measured using intensive pharmacokinetic sampling to generate concentration-time profiles Peripheral blood mononuclear cells PBMC and endocervical cells harvested from whole blood and cervicovaginal lavage respectively will be analyzed for CCR5 receptor occupancy the number of CCR5-expressing HIV target cells and level of T cell activation
DURATION 21 days after the first visit of the last participants Enrollment is expected to take 12 months
SAMPLE SIZE 30 subjects 10 subjects per study group
POPULATION HIV-negative healthy women age 18 years or older with normal menses
DESIGN This is a prospective observational cohort study with an intensive pharmacokinetic component conducted in HIV-negative healthy women Genital tract and whole blood samples will be collected before during and after treatment with 7 days of oral MVC dosed at 300mg twice daily standard or 300mg daily reduced compared with no treatment control Genital tract and plasma MVC concentration will be measured using intensive pharmacokinetic sampling to generate concentration-time profiles Peripheral blood mononuclear cells PBMC and endocervical cells harvested from whole blood and cervicovaginal lavage respectively will be analyzed for CCR5 receptor occupancy the number of CCR5-expressing HIV target cells and level of T cell activation
DURATION 21 days after the first visit of the last participants Enrollment is expected to take 12 months
SAMPLE SIZE 30 subjects 10 subjects per study group
POPULATION HIV-negative healthy women age 18 years or older with normal menses
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 |
|---|---|---|---|
| ACTSIKL22012 | OTHER | Other | httpsreporternihgovquickSearchKL2TR000455 |
| KL2TR000455 | NIH | None | None |