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


N/A
18 Years
N/A
Open (Enrolling)
Male
Anal Cancer, HIV Infections

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

nine months

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southern California Institute for Research and Education

Authority:

United States: Institutional Review Board

Study ID:

#33245

NCT ID:

NCT00666107

Start Date:

June 2008

Completion Date:

June 2012

Related Keywords:

  • Anal Cancer
  • HIV Infections
  • HPV
  • HIV
  • Gardasil
  • Vaccine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Anus Neoplasms

Name

Location

Va Long Beach Healthcare SystemLong Beach, California  90822