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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)

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ClinicalTrials.gov Identifier: NCT00666107
Recruitment Status : Unknown
Verified November 2010 by Southern California Institute for Research and Education.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2008
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Anal Cancer HIV Infections Biological: Gardasil

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2008
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: Gardasil
    Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6
    Other Name: HPV quadrivalent vaccine

Outcome Measures

Primary Outcome Measures :
  1. Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies [ Time Frame: nine months ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666107

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


Responsible Party: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00666107     History of Changes
Other Study ID Numbers: #33245
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: November 2010

Keywords provided by Southern California Institute for Research and Education:

Additional relevant MeSH terms:
HIV Infections
Anus Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs