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Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men (MIRB #862)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Southern California Institute for Research and Education.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00666107
First received: April 22, 2008
Last updated: March 12, 2012
Last verified: November 2010
  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

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies [ Time Frame: nine months ] [ Designated as safety issue: No ]
  • Determine percentage of subjects who seroconverted or mounted a significant serologic response to each of the 2 antigens 16 and 18 [ Time Frame: 8-9 months ] [ Designated as safety issue: No ]
  • Determine how many patients, if any, develop evidence of anal HPV infection, as measured by development of a positive HPV test. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: nine months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Gardasil
    Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6
    Other Name: HPV quadrivalent vaccine
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666107

Locations
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822-5201
Sponsors and Collaborators
Southern California Institute for Research and Education
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stephen M Berman, M.D., Ph.D. Southern California Institute for Research and Education
  More Information

Publications:

Responsible Party: 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: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
HPV
HIV
Gardasil
Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014