Clinical Trials Program
临床试验计划
基本信息
- 批准号:10224783
- 负责人:
- 金额:$ 19.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-18 至 2022-03-31
- 项目状态:已结题
- 来源:
- 关键词:Acetic AcidsAddressAdjuvantAffectAgeAlgorithmsAreaBiological AssayCaribbean regionCervicalCervical Cancer ScreeningCervical Intraepithelial NeoplasiaCessation of lifeChildClinicalClinical TrialsColposcopyCommunitiesCorrelative StudyCountryCytologyDetectionDiagnosisDiseaseDominican RepublicDoseEnrollmentGoalsHIVHIV InfectionsHealthHuman Papilloma Virus VaccinationHuman Papilloma Virus VaccineHuman Papilloma Virus-Related Malignant NeoplasmHuman PapillomavirusHuman papilloma virus infectionImaging technologyImmuneImmunopreventionImprove AccessIncidenceInfrastructureInternationalLatin AmericaLeadLesionMalignant NeoplasmsMalignant neoplasm of cervix uteriMeasuresMemory B-LymphocyteMethodsMonoclonal AntibodiesOperative Surgical ProceduresOutcomePap smearPapillomavirus Transforming Protein E6ParticipantPatientsPersonsPeruPopulationPreventionProviderQuality of lifeRandomized Controlled TrialsRecurrenceRegimenResearchResourcesRiskScheduleSirolimusSiteTestingTimeTriageVaccinationVaccinesVisualWomanYouthautomated visual evaluationbasecancer preventioncervical cancer preventiondesignexperiencegirlshigh riskimplementation facilitationimprovedimproved outcomelow and middle-income countriesnew technologynovelovertreatmentpoint of carepremalignantpreventprevention serviceprogramsresponsescreeningstandard of caretreatment strategytumor microenvironment
项目摘要
PROJECT SUMMARY – CLINICAL TRIALS PROGRAM
The goal of the Clinical Trials Program is to address the dual burden of HIV infection and HPV-associated
cervical cancer in Latin America and the Caribbean (LAC). Over 270,000 women die every year of cervical
cancer, and it disproportionately affects women in low- and middle-income countries (LMICs) where
approximately 90% of cervical cancer deaths occur. Peru and the Dominican Republic experience a 3-fold
higher incidence of cervical cancer than the US, as well as high rates of HIV infection, especially in vulnerable
key populations. Women and children living with HIV (WLWH and CLWH) are more likely to have persistent
HPV and high-grade lesions, and they are at higher risk of progression to cancer than HIV-uninfected women.
Addressing the needs of HIV-infected persons at risk for HPV-associated cancers in LMICs involves improving
access to HPV vaccines and more effective screening for and treatment of cervical high-grade lesions. Instead
of replicating the infrastructure needed for screening used in high-resource settings, the clinical trials proposed
here seek to use a new combination of prevention and treatment methods aimed at point-of-care with low-
infrastructure support. We will leverage and strengthen existing research capacity in Seattle and the LAC sites
to explore sustainable solutions that are acceptable to local providers and patients. This includes investigating
optimal HPV vaccine schedules for HIV+ children, assessing new HPV tests and visual imaging technologies
to help clinicians to perform high-quality screening and triage, and testing non-surgical approaches to improve
outcomes of cervical cancer precursors among WLWH. Toward this goal we will conduct three clinical trials:
Trial 1: HPV immunoprevention by vaccination of unexposed children is not optimized for children living with
HIV (CLWH). We will compare longer-term immune (anamnestic) responses among HIV-infected youth (ages
9-13 at the time of enrollment) after 1, 2, or 3 doses of 9-valent HPV vaccine.
Trial 2: Cervical cancer screening and triage among WLWH needs to be optimized to improve detection of
precancerous lesions, reduce overtreatment and facilitate implementation. We will develop a more efficient
algorithm to detect high-grade lesions (CIN2/3) by assessing standard of care (Pap test and visual inspection
with acetic acid), HPV testing, and newer technologies including HPV E6/E7 expression and enhanced visual
inspection (EVA) with automated visual evaluation (AVE), comparable to colposcopy.
Trial 3: Evaluating non-surgical strategies for treatment of high-grade lesions (CIN2/3) diagnosed in
WLWH from Trial 2 in a 2x2 factorial trial of 9-valent HPV vaccine and sirolimus initiated before surgery.
These trials will be framed by the Cervical Cancer Prevention Partnership (C2P2) Center, that brings
together collaborators in Peru, the Dominican Republic, Seattle, with international external scientific and
community advisors. The teams have extensive experience conducting high-quality clinical trials and working
to prevent HPV-related cancers in LMICs and improve health and quality of life for persons living with HIV.
项目摘要-临床试验方案
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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MARGARET M MADELEINE其他文献
MARGARET M MADELEINE的其他文献
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{{ truncateString('MARGARET M MADELEINE', 18)}}的其他基金
Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia: VIVA Trial
HPV L1 疫苗在肛门生殖器肿瘤中的治疗用途:VIVA 试验
- 批准号:
9220396 - 财政年份:2017
- 资助金额:
$ 19.96万 - 项目类别:
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