Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01289106
Status:
UNKNOWN
Last Update Posted:
2011-02-03
First Post:
2011-02-01
Brief Title:
Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects
Sponsor:
Chiang Mai University
Organization:
Chiang Mai University
Study Overview
Official Title:
Open-Label Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
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 purposes of this study include 1 to compare the seroconversion rate of an intensive standard-dose regimen 0 1 2 and 6 months to a standard-dose regimen 01 and 6 months and 2 to compare the seroconversion rate of an intensive double-dose regimen 40 μg at 012 and 6 months to a standard-dose regimen 20 μg at 01 and 6 months of HBV vaccine in HIV-infected adult patients
Detailed Description:
HIV and HBV share similar risk factors and routes of transmission HIVHBV coinfection is associated with greater chance of chronic HBV carrier state higher level of HBV replication and increasing its potential for transmission Currently there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients Standard HBV vaccination 20 μg at 0 1 and 6 months gives seroconversion rate of 33-63 in HIV-infected individuals compared with 90 in healthy individuals This study aims to compare the efficacy of an intensive standard-dose regimen 0 1 2 and 6 months to a standard-dose regimen 01 and 6 months and to compare the seroconversion rate of an intensive double-dose regimen 40 μg at 012 and 6 months to a standard-dose regimen 20 μg at 01 and 6 months of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load
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