Clinical Trials

MainTitle

Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

This study has been completed
Sponsor
AIDS Malignancy Consortium

Collaborator
National Cancer Institute (NCI)
The EMMES Corporation

Information provided by (Responsible Party)
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier
NCT00513526

First received: August 6, 2007
Last updated: August 27, 2015
Last Verified: August 2015
History of Changes
Purpose

Purpose

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

Condition Intervention Phase
Infection
Precancerous Condition

Biological : Gardasil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men

Further study details as provided by AIDS Malignancy Consortium:

Primary Outcome Measures

  • Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine [ Time Frame: All study visits ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline [ Time Frame: Week 28 ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline [ Time Frame: Week 28 ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline [ Time Frame: Week 28 ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline [ Time Frame: Week 28 ]
Secondary Outcome Measures:
  • Longitudinal Changes in CD4+ Cell Count From Baseline [ Time Frame: Week 0, 4, 12, 28 ]
    CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
  • Longitudinal Changes in Plasma HIV-1 RNA From Baseline [ Time Frame: Week 0, 4, 12, 28 ]
    Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
  • HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ]
  • HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ]
  • HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ]
  • HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ]
  • Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series [ Time Frame: Weeks 0, 28 and 76 ]

Enrollment: 112
Study Start Date: November 2007
Study Completion Date: October 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Gardasil
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
Biological: Gardasil

week 0, 8, 24, 128

Other Name: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Detailed Description:

OBJECTIVES:
Primary

  • To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
  • To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.


Secondary
  • To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
  • To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
  • To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
  • To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary
  • To evaluate prevalent and incident HPV infections in the anal canal.
  • To evaluate cytological and histological abnormalities in the anal canal.
  • To evaluate prevalent and incident HPV infections in the oral cavity.
  • To compare oral and anal compartmental shedding of HPV before and after vaccination. OUTLINE: This is a multicenter study.

  • Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.
    After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: Male  
    Accepts Healthy Volunteers: No  

    Criteria

    DISEASE CHARACTERISTICS:
    Inclusion criteria:

    • HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
      • HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
    • Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
    • If receiving antiretroviral therapy:
      • Receipt of antiretroviral therapy for at least 6 months prior to entry
      • No change in antiretroviral therapy within 30 days prior to entry
      • CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
      • HIV-1 RNA < 200 copies/mL within 90 days prior to entry
    • If 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, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry


    Exclusion Criteria:
    • Current or history of anal or perianal carcinoma
    • Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
    • Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN
      • Current or history of anal or peri-anal condyloma is allowed

      • PATIENT CHARACTERISTICS:
        Inclusion criteria:
    • Karnofsky performance status 70-100%
    • Absolute neutrophil count > 750 cells/mm³
    • Hemoglobin ≥ 9.0 g/dL
    • Platelet count ≥ 100,000/mm³
    • Creatinine clearance ≥ 60 mL/min
    • AST and ALT ≤ 3 times ULN
    • Total or conjugated (direct) bilirubin ≤ 2.5 times ULN


    Exclusion Criteria:
    • Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
    • Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
    • Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
    • Hemophilia

    • PRIOR CONCURRENT THERAPY:
      Inclusion criteria:
    • See Disease Characteristics


    Exclusion Criteria:
    • Prior splenectomy
    • Currently receiving anticoagulation therapy other than acetylsalicylic acid
    • Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
      • Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
      • Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
    • Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other
    HPV vaccine

    contacts and locations

    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: NCT00513526

    Locations

    United States, California
    UCLA Clinical AIDS Research and Education (CARE) Center
    Los Angeles, California, United States, 90095-1793
    UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, United States, 94143
    United States, Colorado
    Denver Health Medical Center
    Denver, Colorado, United States, 80204-4507
    United States, Massachusetts
    Boston University Cancer Research Center
    Boston, Massachusetts, United States, 02118
    United States, New York
    Montefiore Medical Center
    Bronx, New York, United States, 10461
    Laser Surgery Care
    New York, New York, United States, 10010
    New York Weill Cornell Cancer Center at Cornell University
    New York, New York, United States, 10021
    United States, Washington
    Benaroya Research Institute at Virginia Mason Medical Center
    Seattle, Washington, United States, 98101

    Sponsors and Collaborators

    AIDS Malignancy Consortium
    National Cancer Institute (NCI)
    The EMMES Corporation

    Investigators

    Study Chair: Timothy J. Wilkin, MD, MPH Weill Medical College of Cornell University
    Principal Investigator: Joel Palefsky, MD University of California, San Francisco
    More Information

    More Information


    Responsible Party: AIDS Malignancy Consortium  
    ClinicalTrials.gov Identifier: NCT00513526   History of Changes  
    Other Study ID Numbers: AMC-052  
      CDR0000559149  
      U01CA121947  
    Study First Received: August 6, 2007  
    Last Updated: August 27, 2015  

    Keywords provided by AIDS Malignancy Consortium:

    infection
    low-grade squamous intraepithelial lesion
    atypical squamous cells of undetermined significance

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    Precancerous Conditions
    Vaccines

    ClinicalTrials.gov processed this data on December 18, 2017
    This information is provided by ClinicalTrials.gov.