Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001115
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
1999-11-02
Brief Title:
The Effect of Acyclovir Treatment of the Herpes Simplex Virus HSV Infection on HIV Levels in the Blood
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus HSV Infection on Peripheral Blood HIV Viral Load
Status:
COMPLETED
Status Verified Date:
1998-06
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:
Part A To evaluate the impact of HSV suppression with acyclovir ACV on HIV burden in patients with asymptomatic HSV infection and at high risk for HSV reactivation
Part B To characterize the change in plasma HIV RNA levels and other measures of HIV burden during and after a 10 day course of ACV treatment for acute HSV infection
Approximately 70 of patients infected with HIV are concurrently infected with HSV There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA There is a need to determine the patterns of association between HSV and HIV
Part B To characterize the change in plasma HIV RNA levels and other measures of HIV burden during and after a 10 day course of ACV treatment for acute HSV infection
Approximately 70 of patients infected with HIV are concurrently infected with HSV There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA There is a need to determine the patterns of association between HSV and HIV
Detailed Description:
Approximately 70 of patients infected with HIV are concurrently infected with HSV There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA There is a need to determine the patterns of association between HSV and HIV
Part A 60 approved HIV infected patients will be randomized to either suppressive ACV therapy or matching placebo for 12 weeks Serology for HSV serum antibodies will be obtained at screening and a full history and physical exam will be performed on Day 1 and interval examinations at Weeks 2 4 8 and 12 Extensive clinical exams will be conducted on a regular schedule throughout the 12 weeks
Part B 15 approved HIV infected patients will receive treatment with ACV until resolution of the lesion All patients will be monitored on Day 9-12 of ACV therapy for crusting and resolutions of HSV lesions and will be followed for 35 months
AS PER AMENDMENT 31197 Noncommercial active acyclovir will be made available for Part A patients wo develop acute HSV while on study and for Part B patients who develop acute HSV after completion of the acute phase of treatment ie during the follow-up phase
Part A 60 approved HIV infected patients will be randomized to either suppressive ACV therapy or matching placebo for 12 weeks Serology for HSV serum antibodies will be obtained at screening and a full history and physical exam will be performed on Day 1 and interval examinations at Weeks 2 4 8 and 12 Extensive clinical exams will be conducted on a regular schedule throughout the 12 weeks
Part B 15 approved HIV infected patients will receive treatment with ACV until resolution of the lesion All patients will be monitored on Day 9-12 of ACV therapy for crusting and resolutions of HSV lesions and will be followed for 35 months
AS PER AMENDMENT 31197 Noncommercial active acyclovir will be made available for Part A patients wo develop acute HSV while on study and for Part B patients who develop acute HSV after completion of the acute phase of treatment ie during the follow-up phase
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: