Anal Cancer Clinical Trial
Official title:
AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males
Verified date | August 2020 |
Source | AIDS Malignancy Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 149 |
Est. completion date | December 12, 2017 |
Est. primary completion date | December 12, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 13 Years to 26 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | University of Puerto Rico Comprehensive Cancer Center | San Juan | |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Fenway Community Health | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Montefiore Medical Center | Bronx | New York |
United States | John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois |
United States | Ruth M. Rothstein Core Center at Cook County Hospital | Chicago | Illinois |
United States | Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston | Texas |
United States | Thomas Street Health Center | Houston | Texas |
United States | Moores UCSD Cancer Center | La Jolla | California |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles | California |
United States | St. Jude's Children's Research Hospital | Memphis | Tennessee |
United States | Laser Surgery Care | New York | New York |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AIDS Malignancy Consortium | AIDS and Cancer Specimen Resource, Merck Sharp & Dohme Corp., National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA | Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline. | Post Month 7 through Month 24 | |
Primary | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA | Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline. | Post Month 7 through Month 24 | |
Primary | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA | Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline. | Post Month 7 through Month 24 | |
Primary | Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA | Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline. | Post Month 7 through Month 24 | |
Primary | Incidence of Persistent Anogenital Infection With HPV 6 DNA | Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site. | Post Month 7 through Month 24 | |
Primary | Incidence of Persistent Anogenital Infection With HPV 11 DNA | Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site. | Post Month 7 through Month 24 | |
Primary | Incidence of Persistent Anogenital Infection With HPV 16 DNA | Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site. | Post Month 7 through Month 24 | |
Primary | Incidence of Persistent Anogenital Infection With HPV 18 DNA | Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site. | Post Month 7 through Month 24 | |
Primary | Incidence of HGAIN Associated With HPV 6 | Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline. | Post month 7 through month 24 | |
Primary | Incidence of HGAIN Associated With HPV 11 | Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline. | Post month 7 through month 24 | |
Primary | Incidence of HGAIN Associated With HPV 16 | Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline. | Post month 7 through month 24 | |
Primary | Incidence of HGAIN Associated With HPV 18 | Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline. | Post month 7 through month 24 | |
Primary | Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. | Post month 7 through month 24 | |
Primary | Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. | Post month 7 through month 24 | |
Primary | Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. | Post month 7 through month 24 | |
Primary | Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants | Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline. | Post month 7 through month 24 | |
Secondary | Occurrence of Grade = 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine | Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine. | Through Month 24 | |
Secondary | Geometric Mean Titers for HPV 6 | Geometric mean concentration of antibodies for HPV 6 at each visit | Baseline through month 24 | |
Secondary | Geometric Mean Titers for HPV 11 | Geometric mean concentration of antibodies for HPV 11 at each visit | Baseline through month 24 | |
Secondary | Geometric Mean Titers for HPV 16 | Geometric mean concentration of antibodies for HPV 16 at each visit | Baseline through 24 months | |
Secondary | Geometric Mean Titers for HPV 18 | Geometric mean concentration of antibodies for HPV 18 at each visit | Baseline through 24 months | |
Secondary | Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months | at 7 and 24 Months | |
Secondary | Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months | at 7 and 24 Months | |
Secondary | Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months | at 7 and 24 Months | |
Secondary | Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level | Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months | at 7 and 24 Months |
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