Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02316444
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2014-12-10
Brief Title:
Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
Status:
COMPLETED
Status Verified Date:
2019-01
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 aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus HBV in subjects already infected with human immunodeficiency virus HIV
Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospitals HIV care clinic
Primary objectives are to assess
1 The role of CD4-cell count and HIV viral loads on the HBV vaccine response
2 The role of highly active antiretroviral therapy HAART on the HBV vaccine response
The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up
Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospitals HIV care clinic
Primary objectives are to assess
1 The role of CD4-cell count and HIV viral loads on the HBV vaccine response
2 The role of highly active antiretroviral therapy HAART on the HBV vaccine response
The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up
Detailed Description:
This is an interventional study in which researchers will recruit HIV positive individuals who do not have hepatitis B HBV negative in order to assess the effectiveness of a hepatitis B vaccine in 2 subgroups
1 Those who have received less than 3 months treatment or no treatment with highly active antiretroviral drugs HAART naive
2 Those who have received at least 3 months of treatment with highly active antiretroviral drugs HAART exposed
All study participants will receive vaccination against HBV
There will be 6-12 clinic visits depending on 1 whether or not the participant responds to the standard 3-dose vaccination protocol and 2 whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose
The first visit will be to determine if the participant is eligible for the study If eligible the participant will receive one dose of vaccine at each of the following three visits The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol The sixth visit will be to discuss the outcome of the vaccination with the participant Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point However if a participant fails to respond to the initial 3-dose vaccine protocol he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before but off protocol
Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits
1 Those who have received less than 3 months treatment or no treatment with highly active antiretroviral drugs HAART naive
2 Those who have received at least 3 months of treatment with highly active antiretroviral drugs HAART exposed
All study participants will receive vaccination against HBV
There will be 6-12 clinic visits depending on 1 whether or not the participant responds to the standard 3-dose vaccination protocol and 2 whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose
The first visit will be to determine if the participant is eligible for the study If eligible the participant will receive one dose of vaccine at each of the following three visits The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol The sixth visit will be to discuss the outcome of the vaccination with the participant Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point However if a participant fails to respond to the initial 3-dose vaccine protocol he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before but off protocol
Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits
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