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

September 24, 2010
February 21, 2014
June 2011
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Any incident of AIN or anal condyloma associated with HPV 16, 18, 6, or 11 DNA [ Designated as safety issue: No ]
  • Diagnosis of HGAIN related to vaccine HPV types at any time during the study [ Designated as safety issue: No ]
  • Any persistent anogenital infection with HPV 16, 18, 6, or 11 DNA [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01209325 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurrence of grade ≥ 3 AEs that are possibly, probably, or definitely related to the vaccine [ Designated as safety issue: Yes ]
  • Longitudinal changes in plasma HIV-1 RNA and CD4+ cell count from baseline [ 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 [ Designated as safety issue: No ]
  • Level of HPV DNA before and after vaccination [ Designated as safety issue: No ]
  • Type and level of HPV DNA in the oral cavity [ Designated as safety issue: No ]
  • HPV strain variation before and after receipt of the quadrivalent HPV vaccine [ Designated as safety issue: No ]
  • Baseline prevalence and incidence of penile and anal gonorrhea and Chlamydia infection [ Designated as safety issue: No ]
  • Change in young men's risk perceptions, sexual behaviors, and STI diagnosis after HPV vaccination [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anal Cancer
  • Nonneoplastic Condition
  • Penile Cancer
  • Precancerous Condition
  • Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • Other: laboratory biomarker analysis
Experimental: Vaccination
Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
Interventions:
  • Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Male
13 Years to 26 Years
No
United States
 
NCT01209325
CDR0000685816, AMC-072, U01CA121947
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: Joel Palefsky, MD University of California, San Francisco
AIDS Malignancy Clinical Trials Consortium
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP