HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- AIDS-Related Human Papillomavirus Infection
- High Grade Cervical Squamous Intraepithelial Neoplasia
- HIV Infection
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 25 years and 125 years
- Gender
- Only males
Description
At screening, potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy to confirm the absence of cervical cancer. If eligible, the participant will be randomized to receive either the 9-valent HPV ...
At screening, potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy to confirm the absence of cervical cancer. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later for the second dose of vaccine or placebo. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies before the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at weeks 26, 52, 78, and 104, and will have cervical cytology and colposcopy with biopsies at weeks 26, 52, and 104.
Tracking Information
- NCT #
- NCT03284866
- Collaborators
- National Cancer Institute (NCI)
- University of Arkansas
- AIDS and Cancer Specimen Resource
- Merck Sharp & Dohme Corp.
- The Emmes Company, LLC
- University of California, Los Angeles
- Investigators
- Principal Investigator: Carla Chibwesha University of Witwatersrand, South Africa
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