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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Cancer, HIV Infections

Intervention / Treatment
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* Biological: Gardasil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Gardasil|Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies |  | nine months | 
| Determine percentage of subjects who seroconverted or mounted a significant serologic response to each of the 2 antigens 16 and 18 |  | 8-9 months | 
| Determine how many patients, if any, develop evidence of anal HPV infection, as measured by development of a positive HPV test. |  | 9 months | 
| Determine if vaccinations will activate the subject's immune systems sufficiently that the HIV-1 viral load either increases from the baseline value, or becomes detectable and stays detectable after being undetectable at the baseline visit |  | nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, HIV, Gardasil, Vaccine