Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men

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Brief Title

Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men

Official Title

Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-infected Men

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies


Condition

Anal Cancer

Intervention

Gardasil


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

150

Start Date

June 2008

Completion Date

June 2012

Primary Completion Date

June 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Male veterans

          -  Age 18 or older

          -  HIV-positive

          -  Seen regularly in the ID Primary Care Clinic at the VA Long Beach Healthcare System

        Exclusion Criteria:

          -  None
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephen M Berman, M.D., Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00666107

Organization ID

#33245


Responsible Party

Sponsor

Study Sponsor

Southern California Institute for Research and Education

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Stephen M Berman, M.D., Ph.D., Principal Investigator, Southern California Institute for Research and Education


Verification Date

November 2010