Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
This study is currently recruiting participants.
Verified May 2013 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01209325
First received: September 24, 2010
Last updated: May 3, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Human Papillomaviruses
U.S. FDA Resources
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: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209325
Locations
| United States, California | |
| Moores UCSD Cancer Center | Not yet 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 | |
| UCLA Clinical AIDS Research and Education (CARE) Center | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Clinical Trials Office 310-557-9062 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Fenway Community Health | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Kenneth H. Mayer, MD 617-267-0900 | |
| 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 | |
| Laser Surgery Care | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: Stephen E. Goldstone, MD 212-242-6500 | |
| 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 | |
| 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 | |
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: | May 3, 2013 |
| 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:
|
Anus Neoplasms HIV Seropositivity Precancerous Conditions Penile Neoplasms Warts 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 |
ClinicalTrials.gov processed this record on June 17, 2013