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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)
This study is currently recruiting participants.
Verified by Southern California Institute for Research and Education, December 2008
Sponsors and Collaborators: Southern California Institute for Research and Education
Merck
Information provided by: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00666107
  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

MedlinePlus related topics: AIDS Anal Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-Infected Men

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: December 2009
Estimated Primary Completion Date: December 2009 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666107

Contacts
Contact: Stephen M Berman, M.D., Ph.D. (562) 826-8000 ext 2841 stephen.berman2@va.gov

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

Publications:
Chin-Hong PV, Palefsky JM. Natural history and clinical management of anal human papillomavirus disease in men and women infected with human immunodeficiency virus. Clin Infect Dis. 2002 Nov 1;35(9):1127-34. Epub 2002 Oct 14.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27.
Emeny RT, Wheeler CM, Jansen KU, Hunt WC, Fu TM, Smith JF, MacMullen S, Esser MT, Paliard X. Priming of human papillomavirus type 11-specific humoral and cellular immune responses in college-aged women with a virus-like particle vaccine. J Virol. 2002 Aug;76(15):7832-42.
Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8.
Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Høye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. Epub 2007 Apr 20.
Bower M, Powles T, Newsom-Davis T, Thirlwell C, Stebbing J, Mandalia S, Nelson M, Gazzard B. HIV-associated anal cancer: has highly active antiretroviral therapy reduced the incidence or improved the outcome? J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1563-5.
Bozzette SA, Phillips B, Asch S, Gifford AL, Lenert L, Menke T, Oritz E, Owens D, Deyton L. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Med Care. 2000 Jun;38(6 Suppl 1):I60-9. Review.

Responsible Party: Southern California Institute for Research and Education ( Stephen M. Berman, M.D., Ph.D. )
Study ID Numbers: #33245
Study First Received: April 22, 2008
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00666107  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Rectal Diseases
Immunologic Deficiency Syndromes
Intestinal Neoplasms
Rectal neoplasm
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Gastrointestinal Neoplasms
Anal cancer
Papilloma
Rectal cancer
Anus Neoplasms
Retroviridae Infections
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Site
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection
Anus Diseases

ClinicalTrials.gov processed this record on January 16, 2009