Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161434
Status:
COMPLETED
Last Update Posted:
2008-01-10
First Post:
2005-09-08
Brief Title:
A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1 HSV-2 Coinfected Persons
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV
Detailed Description:
Sexually transmitted diseases and genital ulcer disease GUD contribute significantly to the spread of HIV as their presence is associated with higher rates of HIV acquisition in susceptible individuals Herpes simplex virus-2 HSV-2 is a major cause of GUD in developed and developing countries
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV
This study is a randomized double-blind placebo-controlled crossover trial Sixty men who have sex with men MSM will be randomized to first receive either valacyclovir 1 gram once a day or matching placebo for 8 weeks After a 2-week washout period during which all participants receive placebo subjects then switch to the other treatment for the next 8 weeks
At screening informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination At enrollment oral genital and rectal specimens are obtained and additional blood is drawn Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary Following enrollment they are asked to collect daily home oral and genital samples as well as semen samples twice a week for the full 18 weeks of the study Participants return to the clinic three times per week for follow-up for collection of oral and rectal specimens and additional study medication Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV
This study is a randomized double-blind placebo-controlled crossover trial Sixty men who have sex with men MSM will be randomized to first receive either valacyclovir 1 gram once a day or matching placebo for 8 weeks After a 2-week washout period during which all participants receive placebo subjects then switch to the other treatment for the next 8 weeks
At screening informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination At enrollment oral genital and rectal specimens are obtained and additional blood is drawn Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary Following enrollment they are asked to collect daily home oral and genital samples as well as semen samples twice a week for the full 18 weeks of the study Participants return to the clinic three times per week for follow-up for collection of oral and rectal specimens and additional study medication Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form
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 |
|---|---|---|---|
| P01AI030731 | NIH | None | httpsreporternihgovquickSearchP01AI030731 |