Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362596
Status:
COMPLETED
Last Update Posted:
2006-08-10
First Post:
2006-08-08
Brief Title:
A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women Chiang Rai Thailand
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women Chiang Rai Thailand
Status:
COMPLETED
Status Verified Date:
2006-08
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:
Herpes infection is an important co-factor in HIV transmission A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 HSV-2 in Thailand
Detailed Description:
65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics family planning clinics postnatal clinics community based organizations and community outreach in Chiang Rai Thailand
Our study objectives are
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding
To determine the association between HIV and HSV genital shedding and the effect of acyclovir suppressive therapy on this association
To determine the acceptability of acyclovir suppressive therapy for women with HIV infection
To evaluate the association of genital symptoms and HIV or HSV genital shedding
To evaluate the association between cervicovaginal CVL specimens and self-collected genital swabs for detection of HIV and HSV-2
Our study objectives are
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding
To determine the association between HIV and HSV genital shedding and the effect of acyclovir suppressive therapy on this association
To determine the acceptability of acyclovir suppressive therapy for women with HIV infection
To evaluate the association of genital symptoms and HIV or HSV genital shedding
To evaluate the association between cervicovaginal CVL specimens and self-collected genital swabs for detection of HIV and HSV-2
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