Spots Global Cancer Trial Database for Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
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Trial Identification
Brief Title: Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
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
Study ID: NCT00513526
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men. * To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline. Secondary * To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series. * To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response. * To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline. * To evaluate the oral levels of serum IgA before and after the vaccination series. Tertiary * To evaluate prevalent and incident HPV infections in the anal canal. * To evaluate cytological and histological abnormalities in the anal canal. * To evaluate prevalent and incident HPV infections in the oral cavity. * To compare oral and anal compartmental shedding of HPV before and after vaccination. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Denver Health Medical Center, Denver, Colorado, United States
Boston University Cancer Research Center, Boston, Massachusetts, United States
Montefiore Medical Center, Bronx, New York, United States
Laser Surgery Care, New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Benaroya Research Institute at Virginia Mason Medical Center, Seattle, Washington, United States
Contact Details
Name: Timothy J. Wilkin, MD, MPH
Affiliation: Weill Medical College of Cornell University
Role: STUDY_CHAIR
Name: Joel Palefsky, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
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