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

NCT ID: NCT00666107

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-06-30

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.

Conditions

Anal Cancer; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Gardasil

Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

HPV quadrivalent vaccine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Southern California Institute for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Southern California Institute for Research and Education

Locations

VA Long Beach Healthcare System

Long Beach, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 17494925 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 17499406 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15577408 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10843271 (View on PubMed)

Other Identifiers

#33245

Identifier Type: -

Identifier Source: org_study_id