Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378976
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2006-09-19
Brief Title:
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 HSV-2 Co-infected Men
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Crossover Trial of Valacyclovir for Suppression of HSV and HIV Shedding in HIV-1 HSV-2 Coinfected Men Who Have Sex With Men MSM
Status:
COMPLETED
Status Verified Date:
2013-08
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:
Over 80 of HIV-1 infected persons are also seropositive for HSV-2 Increasingly clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness The evidence suggests that that HSV is an important cofactor in HIV transmission
The trials purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation
This proof-of-concept randomized double-blind placebo controlled crossover trial of 20 HIVHSV-2 co-infected men assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions
The trials purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation
This proof-of-concept randomized double-blind placebo controlled crossover trial of 20 HIVHSV-2 co-infected men assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions
Detailed Description:
Herpes simplex virus type 2 HSV-2 is common among HIV infected persons HSV-2 reactivation is associated with increased plasma and genital HIV-1 levels and in vitro HSV-2 upregulates HIV transcription
The trial assessed whether HSV-2 suppression reduces rectal and plasma HIV-1 levels in HIV-1 HSV-2 co-infected men who have sex with men MSM
Conducted in Lima Peru 20 antiretroviral naive HIV-1 and HSV-2 seropositive MSM with CD4 200 were randomly assigned to receive valacyclovir 500 mg bid or placebo for 8 weeks than a 2 week washout period followed by the alternative regimen for 8 weeks Men collected daily home anogenital swabs for HSV DNA PCR had three weekly anoscopy procedures for collection of rectal mucosal secretions for HIV-1 RNA HSV DNA and weekly plasma HIV-1 RNA by PCR Outcomes were plasma and rectal HIV-1 levels by study arm
The trial assessed whether HSV-2 suppression reduces rectal and plasma HIV-1 levels in HIV-1 HSV-2 co-infected men who have sex with men MSM
Conducted in Lima Peru 20 antiretroviral naive HIV-1 and HSV-2 seropositive MSM with CD4 200 were randomly assigned to receive valacyclovir 500 mg bid or placebo for 8 weeks than a 2 week washout period followed by the alternative regimen for 8 weeks Men collected daily home anogenital swabs for HSV DNA PCR had three weekly anoscopy procedures for collection of rectal mucosal secretions for HIV-1 RNA HSV DNA and weekly plasma HIV-1 RNA by PCR Outcomes were plasma and rectal HIV-1 levels by study arm
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 |
|---|---|---|---|
| AI277S7AI38858AI30731 | None | None | None |