HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (NCT03284866) | Clinical Trial Compass
CompletedPhase 3
HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV
Kenya, Malawi, South Africa536 participantsStarted 2019-07-31
Plain-language summary
This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.
Who can participate
Age range25 Years
SexFEMALE
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Inclusion Criteria:
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load, or documentation of receipt of antiretroviral therapy; Note: the term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
* HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected; Note: participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible
* Receipt of ART for at least 180 days prior to randomization
* Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been nat…
What they're measuring
1
Occurrence of cervical high-grade squamous intraepithelial lesions (HSIL) or cervical cancer
Timeframe: After week 4 study visit to week 52 post-randomization