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| Sponsor: | Southern California Institute for Research and Education |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Southern California Institute for Research and Education |
| ClinicalTrials.gov Identifier: | NCT00666107 |
Purpose
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 |
|---|---|
|
Anal Cancer HIV Infections |
Biological: Gardasil |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| VA Long Beach Healthcare System | |
| Long Beach, California, United States, 90822-5201 | |
| Principal Investigator: | Stephen M Berman, M.D., Ph.D. | Southern California Institute for Research and Education |
More Information
| Responsible Party: | Stephen M. Berman, M.D., Ph.D., Southern California Institute for Research and Education |
| ClinicalTrials.gov Identifier: | NCT00666107 History of Changes |
| Other Study ID Numbers: | #33245 |
| Study First Received: | April 22, 2008 |
| Last Updated: | November 10, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
HPV HIV Gardasil Vaccine |
|
HIV Infections Acquired Immunodeficiency Syndrome Anus Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |