Trial record 5 of 14 for:    "Penile Neoplasms"

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01209325
First received: September 24, 2010
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection.

PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.


Condition Intervention Phase
Anal Cancer
Nonneoplastic Condition
Penile Cancer
Precancerous Condition
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Primary Outcome Measures:
  • Any incident of AIN or anal/perianal condyloma associated with HPV 16, 18, 6, or 11 DNA [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • Diagnosis of HGAIN related to vaccine HPV types at any time during the study [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • Any persistent anogenital infection with HPV 16, 18, 6, or 11 DNA [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of grade ≥ 3 AEs that are possibly, probably, or definitely related to the vaccine [ Time Frame: Through Month 24 ] [ Designated as safety issue: Yes ]
  • Longitudinal changes in plasma HIV-1 RNA and CD4+ cell count from baseline [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • Level of HPV antibodies to types 6, 11, 16, and 18 at baseline; one month after the completion of HPV vaccination series; and at weeks 52, 76, and 104 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Level of HPV DNA before and after vaccination [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • Type and level of HPV DNA in the oral cavity [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • HPV strain variation before and after receipt of the quadrivalent HPV vaccine [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]
  • Baseline prevalence and incidence of penile gonorrhea and Chlamydia infection [ Time Frame: Study initiation ] [ Designated as safety issue: No ]
  • Change in young men's risk perceptions, sexual behaviors, and STI diagnosis after HPV vaccination [ Time Frame: Through Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

Primary

  • To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing penile/scrotal condyloma and HPV-6, -11, -16, -18- associated perianal/anal disease in HIV-positive males who have sex with males (MSM) age 13-26 years by comparing the incidence of these lesions among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
  • To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing persistent anogenital infection with HPV-6, -11, -16, or 18 in HIV-positive MSM age 13-26 years by comparing the incidence of persistent infection among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
  • To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing anogenital lesions associated with HPV 6,-11,-16, -18 and persistent infection with these types, in HIV-positive MSM age 13-26 years by comparing the incidence of lesions and persistent infection among those naïve to the relevant types at baseline to incident lesions and infection among MSM naïve to these HPV types who participated in the Merck 020 protocol and who received placebo as part of the protocol.

Secondary

  • To define the safety of the HPV-6, -11, -16, -18 vaccine in HIV-positive MSM age 13-26 years.
  • To evaluate the levels and persistence of HPV 6, 11, 16 and 18 Ab titers after the vaccination series among subjects who are seropositive and seronegative at baseline.
  • To examine whether the protective effect and antibody titers vary as a function of the following at the time of initial vaccination: subject age, HAART treatment status, HIV viral load, CD4 + T-cell count, and nadir CD4 level.

Tertiary

  • To quantify anogenital HPV DNA viral load prior to and after receipt of the quadrivalent HPV vaccine.
  • To identify and quantify HPV types in the oral cavity of HIV-positive MSM prior to and after receipt of the quadrivalent HPV vaccine.
  • To identify HPV strain variants among HIV-positive participants prior to and after receipt of the quadrivalent HPV vaccine.
  • Assess the prevalence and incidence of urinary and gonorrhea and Chlamydia trachomatis infection at baseline and their relationship with prevalent and incident anogenital HPV infection and anal condyloma or AIN.
  • To characterize young men's risk perceptions, sexual behaviors, and STI diagnosis after HPV vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine intramuscularly on day 1 and in weeks 8 and 24.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed up for 2 years.

  Eligibility

Ages Eligible for Study:   13 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Men with a history of at least one male sexual partner

    • "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
  • HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)

    • Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
  • Meets one of the following sets of criteria:

    • Patients receiving antiretroviral therapy:

      • Receipt of antiretroviral therapy for at least 3 months prior to entry
      • No change in antiretroviral therapy within 30 days prior to entry
    • Patients not receiving antiretroviral therapy:

      • CD4-cell count ≥ 350 cells/mm³ within 90 days prior to study entry
      • No plans to start antiretroviral therapy prior to Week 28
  • Normal anal cytological result, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy

    • No current or history of anal or peri-anal carcinoma
    • No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
  • No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
  • No history of HGAIN

PATIENT CHARACTERISTICS:

  • Karnofsky performance score ≥ 70 within 45 days prior to entry
  • Absolute neutrophil count (ANC) > 750 cells/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
  • Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
  • Calculated creatinine clearance ≥ 60 mL/min
  • No hemophilia
  • No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
  • No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
  • No serious medical or psychiatric illness that, in the opinion of the site Investigator, will interfere with the ability of the subject to give informed consent or adhere to the protocol
  • No allergy to yeast or any of the components of Gardasil

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior splenectomy
  • No prior receipt of Gardasil or other HPV vaccine
  • No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
  • No expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup

    • No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
  • Not currently receiving anticoagulation therapy other than acetylsalicylic acid
  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: NCT01209325

Locations
United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: William Wachsman, MD    858-522-8585      
Principal Investigator: William Wachsman, MD         
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027-0700
Contact: Marvin Belzer, PhD    323-660-2450      
Principal Investigator: Marvin Belzer, MD         
UCLA Clinical AIDS Research and Education (CARE) Center Recruiting
Los Angeles, California, United States, 90024
Contact: Clinical Trials Office    310-557-9062      
Principal Investigator: Ron Mitsuyasu, MD         
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Principal Investigator: Joel Palefsky, MD         
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
Principal Investigator: Daniel Reirden, MD         
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-9985
Contact: Jaime Martinez, MD    312-864-3200      
Principal Investigator: Jaime Martinez, MD         
Ruth M. Rothstein Core Center at Cook County Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Jaime Martinez, MD    312-864-3573      
Principal Investigator: Jaime Martinez, MD         
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
Principal Investigator: Elizabeth Stier, MD         
Fenway Community Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kenneth H. Mayer, MD    617-267-0900      
Principal Investigator: Kenneth Mayer, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Lee Ratner, MD    314-362-8826      
Principal Investigator: Lee Ratner, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Donna Futterman, MD    718-882-0023      
Principal Investigator: Donna Futterman, MD         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mark H. Einstein, MD, MS    718-405-8082      
Principal Investigator: Mark Einstein, MD         
Laser Surgery Care Recruiting
New York, New York, United States, 10010
Contact: Stephen E. Goldstone, MD    212-242-6500      
Principal Investigator: Stephen Goldstone, MD         
United States, Tennessee
St. Jude's Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Mary Dillard    901-595-4083      
Principal Investigator: Aditya Guar, MD         
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor    713-798-1297      
Principal Investigator: Mary Paul, MD         
Thomas Street Health Center Recruiting
Houston, Texas, United States, 77009
Contact: Elizabeth Chiao, MD    713-873-4000      
Principal Investigator: Elizabeth Chiao, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: David M. Aboulafia, MD    206-223-6193      
Principal Investigator: David Aboulafia, MD         
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
Principal Investigator: Joel Palefsky, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT01209325     History of Changes
Other Study ID Numbers: CDR0000685816, AMC-072, U01CA121947
Study First Received: September 24, 2010
Last Updated: February 21, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AIDS Malignancy Clinical Trials Consortium:
human papilloma virus infection
anal cancer
penile cancer
HIV infection

Additional relevant MeSH terms:
Penile Neoplasms
Anus Neoplasms
HIV Seropositivity
Precancerous Conditions
Papillomavirus Infections
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Penile Diseases

ClinicalTrials.gov processed this record on August 26, 2014