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. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

March 12, 2012

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies [ Time Frame: nine months ]
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 ]
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 ]
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 ]

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 Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Anal Cancer
HIV Infections

Intervention ^ICMJE

Biological: Gardasil

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

Other Name: HPV quadrivalent vaccine

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

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

Principal Investigator:

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

Southern California Institute for Research and Education

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

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