Status:
COMPLETED
Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance that is made by the body in response to infection or inflammation, and greatly improves cellular immune res...
Detailed Description
Highly active antiretroviral therapy (HAART) has greatly improved the life of HIV infected individuals. Before the introduction of HAART, the impact of HBV infection and liver disease was less promine...
Eligibility Criteria
Inclusion
- HIV infected
- CD4 count of 200 cells/mm3 or more within 30 days prior to study entry
- HIV-1 RNA viral load value obtained within 30 days prior to study entry
- Received HAART for at least 8 weeks prior to study entry OR not on HAART within 8 weeks prior to study entry with no plans to start HAART during the study. Participants receiving HAART must be on stable therapy as defined by the protocol.
- Negative hepatitis B core total antibody (HBcAb total), qualitative hepatitis B surface antibody (HBsAb), and hepatitis B surface antigen (HBsAg) tests within 30 days prior to study entry
- Negative hepatitis C virus (HCV) antibody test, completed within 30 days prior to study entry
- Willing to use acceptable forms of contraception
Exclusion
- HCV antibody or HCV RNA positive at any time prior to study entry
- Previously vaccinated against HBV
- Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, vaccines, interleukins, interferons, growth factors, or intravenous immune globulin within 30 days prior to study entry
- Known allergy or sensitivity to any component of the study drugs
- Active drug or alcohol dependence that would interfere with participation in the study
- Any mental illness that may interfere with the study
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Body weight less than 50 kg (110 lbs)
- Abnormal lab values
- Pregnant or breastfeeding
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00272493
End Date
September 1 2008
Last Update
October 25 2021
Active Locations (11)
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1
Northwestern University CRS
Chicago, Illinois, United States, 60611-3015
2
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60611
3
Washington U CRS
St Louis, Missouri, United States, 63108-2138
4
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016-6481