Clinical trial · Interventional
Effectivity of Protein Purified Derivative Treatment for Anogenital Warts in HIV Patient
Comparison of the Response and Pathomechanism of Purified Tuberculin Unit Protein Injection Therapy for Anogenital Warts with and Without HIV Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Warts | — | UNRESOLVED | — |
| HIV Infection | — | UNRESOLVED | — |
| Tuberculin Purified Protein Derivative | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of protein purified derivative | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIV-positive patients with anogenital warts
- description
- Injection of protein purified derivative
- interventionNames
- Other: Injection of protein purified derivative
- type
- EXPERIMENTAL
- label
- HIV-negative patients with anogenital warts
- interventionNames
- Other: Injection of protein purified derivative
Primary outcomes (1)
- measure
- clinical improvement
- timeFrame
- 3 weeks after treatment
- description
- defined as the reduced in number which describe in number and size which describe in cm cubic of volume which obtained by measuring the length times width times height of the anogenital warts lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Anogenital warts whose diagnosis is made based on anamnesis and physical examination, before receiving intralesional purified protein derivative injection therapy. 2. All stored biological materials that have been previously taken through tissue from anogenital warts patients whose diagnosis was confirmed based on history and physical examination, 3 weeks after receiving the first intralesional purified protein derivative injection therapy. Exclusion Criteria: * 1\. With a history of allergies to purified protein derivative, generalized dermatitis, asthma and skin allergies 2. Currently taking immunosuppressant or immunomodulatory drugs based on the history and clinical examination. 3\. Have an immunodeficiency disease based on anamnesis and clinical examination, except for HIV based on anamnesis, clinical examination and serological examination (anti-HIV). 4\. Have a history of suffering from malignancy based on history and clinical examination. 5\. Infected with tuberculosis based on history, clinical examination and chest radiography. 6\. Infected with other STIs based on history, clinical examination, and serological examination (venereal disease research laboratory (VDRL), Treponema pallidum hemagglutination assay (TPHA), and Hepatitis B surface antigen (HBsAg)).
References
Publications (1)
- BACKGROUNDAchdiat PA, Widjaja S, Suwarsa O, Dwiyana RF, Hindritiani R, Sutedja E, Gunawan H, Usman HA, Rianty F, Maharani RH. Effectiveness and safety of tuberculin purified protein derivative for the treatment of anogenital warts in patients with human immunodeficiency virus. Dermatol Reports. 2024 Jan 30;16(3):9754. doi: 10.4081/dr.2024.9754. eCollection 2024 Sep 2. PMID 39635572