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
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Sponsor:
Southern California Institute for Research and Education
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Southern California Institute for Research and Education
Tracking Information | ||||
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First Submitted Date ICMJE | April 22, 2008 | |||
First Posted Date ICMJE | April 24, 2008 | |||
Last Update Posted Date | March 14, 2012 | |||
Study Start Date ICMJE | June 2008 | |||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00666107 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men | |||
Official Title ICMJE | Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-infected Men | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Biological: Gardasil
Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6
Other Name: HPV quadrivalent vaccine |
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Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
150 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | June 2012 | |||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00666107 | |||
Other Study ID Numbers ICMJE | #33245 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Southern California Institute for Research and Education | |||
Study Sponsor ICMJE | Southern California Institute for Research and Education | |||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | |||
Investigators ICMJE |
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PRS Account | Southern California Institute for Research and Education | |||
Verification Date | November 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |