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Sponsors and Collaborators: |
Southern California Institute for Research and Education Merck |
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Information provided by: | Southern California Institute for Research and Education |
ClinicalTrials.gov Identifier: | NCT00666107 |
This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil) against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.
Condition | Intervention |
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Anal Cancer HIV Infections |
Biological: Gardasil |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-Infected Men |
Estimated Enrollment: | 150 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
This is a prospective pilot study that will attempt to enroll approximately 150-200 HIV-infected males followed regularly in the ID Primary Care Clinic at the VA Long Beach Healthcare System. All consenting patients will be given the HPV vaccine (Gardasil) in three intramuscular injections. Baseline antibody titers to HPV strains 16 and 18 will be obtained at day 0 and repeat levels will be obtained approximately 8 weeks after the completion of the vaccination series to determine whether patients without antibodies at baseline have now produced antibodies, or to determine the change in antibody levels in those patients who have evidence of antibodies prior to the first injection of the vaccine. Patients will undergo routine anal PAP smear with HPV DNA testing at baseline and another PAP smear/HPV test approximately 8 weeks after completion of the series. Patients will report any side effects of the vaccine to the PI. Patients will have blood work to monitor HIV-1 viral load and CD4 lymphocytes counts at various points during the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen M Berman, M.D., Ph.D. | (562) 826-8000 ext 2841 | stephen.berman2@va.gov |
United States, California | |
VA Long Beach Healthcare System | Recruiting |
Long Beach, California, United States, 90822-5201 | |
Principal Investigator: Stephen M Berman, M.D., Ph.D. |
Principal Investigator: | Stephen M Berman, M.D., Ph.D. | Southern California Institute for Research and Education |
Responsible Party: | Southern California Institute for Research and Education ( Stephen M. Berman, M.D., Ph.D. ) |
Study ID Numbers: | #33245 |
Study First Received: | April 22, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00666107 |
Health Authority: | United States: Institutional Review Board |
HPV HIV Gardasil Vaccine |
Sexually Transmitted Diseases, Viral Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Acquired Immunodeficiency Syndrome Intestinal Diseases Rectal Diseases Immunologic Deficiency Syndromes Intestinal Neoplasms Rectal neoplasm Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Gastrointestinal Neoplasms Anal cancer Papilloma Rectal cancer Anus Neoplasms Retroviridae Infections Colorectal Neoplasms |
Neoplasms RNA Virus Infections Neoplasms by Site Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection Anus Diseases |