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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513526 |
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 |
---|---|---|
Cancer-Related Problem/Condition Precancerous/Nonmalignant Condition |
Drug: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
If receiving antiretroviral therapy:
If not receiving antiretroviral therapy:
Exclusion criteria:
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
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
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
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 | |
Laser Surgery Care | |
New York, New York, United States, 10010 | |
Montefiore Medical Center | |
Bronx, New York, United States, 10461 | |
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 |
Study Chair: | Timothy J. Wilkin, MD, MPH | Weill Medical College of Cornell University |
Investigator: | Joel Palefsky, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000559149, AMC-052 |
Study First Received: | August 6, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00513526 |
Health Authority: | United States: Federal Government |
infection low-grade squamous intraepithelial lesion atypical squamous cells of undetermined significance |
Precancerous Conditions HIV Infections Acquired Immunodeficiency Syndrome |
Neoplasms |