Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209313
Status:
COMPLETED
Last Update Posted:
2011-12-16
First Post:
2005-09-13
Brief Title:
Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1 HSV-2 Coinfected Persons in Cameroon
Status:
COMPLETED
Status Verified Date:
2011-12
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 study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces which may increase the infectiousness of HIV-1HSV-2 coinfected persons To test this hypothesis we will control HSV reactivation with acyclovir a safe medication that is proven to reduce HSV shedding and measure HIV levels in blood genital and pharyngeal secretions The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1HSV-2 coinfected individuals
Detailed Description:
The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study In addition half will receive acyclovir for 8 weeks whilst the other half will receive a placebo for 8 weeks The study medication will reverse in the second 8 weeks of the study The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant At each visit genital and oral samples will be collected A blood sample will also be collected For women participants pregnancy test will be performed The clinic will provide both pre- and post-HIV test counseling
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study In addition half will receive acyclovir for 8 weeks whilst the other half will receive a placebo for 8 weeks The study medication will reverse in the second 8 weeks of the study The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant At each visit genital and oral samples will be collected A blood sample will also be collected For women participants pregnancy test will be performed The clinic will provide both pre- and post-HIV test counseling
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 |
|---|---|---|---|
| AI 30731 Project 1 | None | None | None |