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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: | NCT00667563 |
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer.
PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.
Condition | Intervention |
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Cervical Cancer Precancerous/Nonmalignant Condition |
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Genetic: DNA analysis Genetic: polymerase chain reaction Other: cytology specimen collection procedure Procedure: colposcopic biopsy |
Study Type: | Interventional |
Study Design: | Prevention, Open Label |
Official Title: | A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India |
Estimated Enrollment: | 150 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and once in weeks 8 and 24.
Patients undergo cervical cell, buccal cell, and blood sample collection at baseline and periodically after vaccination for immunologic and virologic studies. Cervical cytology specimens are examined by polymerase chain reaction to detect HPV 6, 11, 16, or 18 DNA, as well as 35 other HPV types. Blood samples are analyzed for CD4+/CD8+ cell count, plasma HIV-1 RNA levels, and serum HPV antibody titers for HPV types 6, 11, 16, and 18. Some plasma samples will be stored for future HPV pseudovirion neutralization assays.
After completion of study therapy, patients are followed periodically for up to 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 45 days since prior systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin
Study ID Numbers: | CDR0000593634, AMC-054 |
Study First Received: | April 25, 2008 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00667563 History of Changes |
Health Authority: | Unspecified |
human papilloma virus infection cervical cancer cervical intraepithelial neoplasia HIV infection |
Virus Diseases Precancerous Conditions HIV Seropositivity HIV Infections |
Acquired Immunodeficiency Syndrome Papillomavirus Infections Papilloma Cervical Intraepithelial Neoplasia |
Neoplasms Precancerous Conditions |