Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000953
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Brovavir BV-ara-U SQ 32756 Versus Acyclovir in the Treatment of Localized Herpes Zoster in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2011-02
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:
To compare the efficacy of oral sorivudine brovavir and oral acyclovir for the treatment of localized herpes zoster in HIV-infected patients
HIV-infected patients are at high risk for herpesvirus infections including varicella-zoster virus VZV infections also called shingles Acyclovir an approved drug is widely used to treat VZV infections in the HIV population Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients a study is needed to test the relative efficacy of brovavir an experimental antiviral drug versus that of acyclovir
HIV-infected patients are at high risk for herpesvirus infections including varicella-zoster virus VZV infections also called shingles Acyclovir an approved drug is widely used to treat VZV infections in the HIV population Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients a study is needed to test the relative efficacy of brovavir an experimental antiviral drug versus that of acyclovir
Detailed Description:
HIV-infected patients are at high risk for herpesvirus infections including varicella-zoster virus VZV infections also called shingles Acyclovir an approved drug is widely used to treat VZV infections in the HIV population Since no data from controlled studies are available to define the role of antiviral therapy for VZV infections in HIV-infected patients a study is needed to test the relative efficacy of brovavir an experimental antiviral drug versus that of acyclovir
One hundred-eighty patients are randomized to receive either brovavir or acyclovir as follows brovavir or its matching placebo once daily and acyclovir or its matching placebo five times daily Treatment continues for 10 days Entry into the study must occur within 72 hours of lesion development Patients are followed in person daily or at regular intervals during study drug administration and on days 14 21 and 28 and then monthly by telephone for 11 months thereafter
One hundred-eighty patients are randomized to receive either brovavir or acyclovir as follows brovavir or its matching placebo once daily and acyclovir or its matching placebo five times daily Treatment continues for 10 days Entry into the study must occur within 72 hours of lesion development Patients are followed in person daily or at regular intervals during study drug administration and on days 14 21 and 28 and then monthly by telephone for 11 months thereafter
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol -38-022 | None | None | None |