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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infection; Anogenital Warts; Tuberculin Purified Protein Derivative
• Intervention / Treatment: Other: Injection of protein purified derivative

Detailed Description

Research Design Research on the response to administration of intralesional PPD-2TU therapy in warts to changes in levels of various cytokines locally and systemically.

Data, Data Collection Techniques and Data Sources The data used is primary data. Primary data is the result of examination anogenital warts patients who were then given PP2-TU therapy at varying doses, blood serum and histopathological preparations are taken before injection and 3 weeks after the injection.

Sample Taking/Selection The research sample was anogenital warts patients who were treated at the Infection Polyclinic Sexually Transmitted Hospital Dr. Hasan Sadikin Bandung, using consecutive sampling for each group, 15 anogenital warts patients with and 15 patient without HIV infection were given purified protein derivative injection.

Data Validity and Reliability The validity of laboratory examination data can be guaranteed due to inspection. Laboratory work is carried out in the clinical pathology and anatomical pathology laboratories of the Hospital Dr Hasan Sadikin who has international standards.

Independent variable: Patients with anogenital warts Dependent variables: Clinical response, levels of IFN-α, IFN-γ, and IL-2 in the blood and tissue.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pati Aji Achdiat, PhD, Dermatovenereologist; Phone Number: +6281322750101; Email: pati.aji.achdiat@unpad.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV-positive patients with anogenital warts; Injection of protein purified derivative	Other: Injection of protein purified derivative; Injection of purified protein derivative for anogenital warts in HIV and non HIV patient, on the largest lesion
Experimental: HIV-negative patients with anogenital warts	Other: Injection of protein purified derivative; Injection of purified protein derivative for anogenital warts in HIV and non HIV patient, on the largest lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical improvement	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	3 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cytokine change in blood and tissue	the cytokine change will be measure using ELISA for detection int the blood specimen, while cytokine change in the tissue sample will be measure with mRNA expression using PCR	3 weeks after treatment

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran

Publications and helpful links

General Publications

• Achdiat, P. A., Widjaja, S., Suwarsa, O., Dwiyana, R. F., Hindritiani, R., Sutedja, E., … & Maharani, R. H. (2024). Effectiveness and safety of tuberculin purified protein derivative for the treatment of anogenital warts in patients with human immunodeficiency virus. Dermatology Reports. https://doi.org/10.4081/dr.2024.9754

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Estimated): September 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: HIV infection; tuberculin purified protein derivative; anogenital warts
• Additional Relevant MeSH Terms: Skin Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome; Warts; Condylomata Acuminata
• Other Study ID Numbers: DV-202407.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Its need the Indonesian goverment clearance for do so

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No