Clinical Trial

Effectivity of Protein Purified Derivative Treatment for Anogenital Warts in HIV Patient

Not Yet Recruiting Phase 2/3
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Record status
This record was last updated September 19, 2024 (before its estimated September 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Warts are a common viral infection of the skin and are prevalent throughout the world, with an overall prevalence in the United States estimated at 2-20%. The incidence of anogenital warts occurs more frequently in HIV-infected patients, with a seven-fold increase in risk compared to patients without HIV infection. Available treatments for anogenital warts can only reduce, but cannot eradicate, HPV infection. There are many therapeutic options for treating anogenital warts, but none can prevent recurrence. Immunotherapy has become one of the best therapeutic options for warts caused by HPV infection because it increases the immune response to HPV infection, resulting in remission, both in lesions that receive direct and indirect intralesional therapy. Immunotherapy, acts as a basic principle to enhance cell-mediated immunity for wart clearance. Apart from low recurrence, regression in immunotherapy for warts due to HPV infection generally occurs without cicatrices, so it is a consideration in choosing therapy, including anogenital warts. Various types of immunotherapy have been used, one of which is purified protein derivative, which can be used as an alternative therapy option for anogenital warts. In a previous case report, even though an HIV patient had an abnormal immune system, tuberculin protein purified derivative therapy, immunotherapy provided a significant clinical response in the form of a reduction in lesion size, compared to patients who were not given therapy. Research regarding the comparison of the response to tuberculin protein purified derivative therapy in anogenital warts patients with and without HIV infection has never been reported. Therefore, researchers are interested in examining the comparison of the response to tuberculin purified protein derivative therapy in anogenital warts patients between those with and without HIV infection and knowing the comparison of local and systemic cytokine changes when administering anogenital wart therapy with tuberculin protein purified derivative between those with and without HIV infection.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-04.
Trial Details
NCT Number NCT06587542
Lead Sponsor Universitas Padjadjaran
Conditions Anogenital Warts, HIV Infection, Tuberculin Purified Protein Derivative
Enrollment 30 participants
Start Date 2024-09-15
Primary Completion 2025-09-15 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-19