HIV/AIDS and Infections Clinical Trial
Official title:
Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
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 Hospital's 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.
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.
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