Status:
COMPLETED
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Anal Cancer
Nonneoplastic Condition
Eligibility:
MALE
13-26 years
Phase:
PHASE2
Brief Summary
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 ...
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2017
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT01209325
Start Date
June 28 2011
End Date
December 12 2017
Last Update
August 11 2020
Active Locations (19)
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1
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
2
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90024
3
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
4
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115