HIV Infections Clinical Trial
Official title:
Improving Immune Response to Hepatitis B Vaccine in HIV-positive Subjects Using Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) as a Vaccine Adjuvant: A Phase II Open-Label Pilot Study
NCT number | NCT00272493 |
Other study ID # | A5220 |
Secondary ID | 10148ACTG A5220 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Est. completion date | September 2008 |
Verified date | May 2012 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 responses. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus (HBV) vaccination in HIV infected individuals.
Status | Completed |
Enrollment | 48 |
Est. completion date | September 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University CRS | Chicago | Illinois |
United States | Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois |
United States | Univ. of Cincinnati CRS | Cincinnati | Ohio |
United States | Case CRS | Cleveland | Ohio |
United States | MetroHealth CRS | Cleveland | Ohio |
United States | The Ohio State Univ. AIDS CRS | Columbus | Ohio |
United States | Univ. of Rochester ACTG CRS | Durham | North Carolina |
United States | NY Univ. HIV/AIDS CRS | New York | New York |
United States | Univ. of Rochester ACTG CRS | Rochester | New York |
United States | Washington U CRS | Saint Louis | Missouri |
United States | University of Washington AIDS CRS | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, Snydman DR. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis. 2001 Feb 1;32(3):492-7. Epub 2001 Jan 23. — View Citation
Laurence JC. Hepatitis A and B immunizations of individuals infected with human immunodeficiency virus. Am J Med. 2005 Oct;118 Suppl 10A:75S-83S. Review. — View Citation
Overton ET, Kang M, Peters MG, Umbleja T, Alston-Smith BL, Bastow B, Demarco-Shaw D, Koziel MJ, Mong-Kryspin L, Sprenger HL, Yu JY, Aberg JA. Immune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating f — View Citation
Sasaki Md, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine. 2003 Nov 7;21(31):4545-9. — View Citation
Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Muñoz A, Thomas DL; Multicenter AIDS Cohort Study. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002 Dec 14;360(9349):1921-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative hepatitis B surface antibody (HBsAb) | At Week 16 | ||
Primary | Occurrence of Grade 3 or higher adverse events (including hypersensitivity reaction) related to study regimens and HIV viral load increase greater than 1 log(10) | Throughout the study | ||
Secondary | Quantitative HBsAb 24 and 48 weeks after completion of HBV vaccination series | At Weeks 36 and 60 | ||
Secondary | HBsAb response, defined as titer greater than 10 mlU/ml at 4, 24, and 48 weeks after completion of HBV vaccination series | At Weeks 16, 36, and 60 | ||
Secondary | Changes in HIV viral load from baseline | At Weeks 4, 16, and 60 | ||
Secondary | Changes in white blood cell and absolute neutrophil count from baseline | At Weeks 4, 16, and 36 | ||
Secondary | Occurrence of Grade 2 or higher adverse events | Throughout the study | ||
Secondary | Changes in CD4 count from baseline | At Weeks 4, 16, and 60 |
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