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

NCT06587542 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DV-202407.01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anogenital Warts; HIV Infection; Tuberculin Purified Protein Derivative

Keywords

anogenital warts; HIV infection; tuberculin purified protein derivative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cytokine change in blood and tissue

  3 weeks after treatment

Study Arms (2)

HIV-positive patients with anogenital warts

EXPERIMENTAL

Injection of protein purified derivative

Other: Injection of protein purified derivative

HIV-negative patients with anogenital warts

EXPERIMENTAL

Other: Injection of protein purified derivative

Interventions

Injection of protein purified derivative OTHER

Injection of purified protein derivative for anogenital warts in HIV and non HIV patient, on the largest lesion

HIV-negative patients with anogenital warts; HIV-positive patients with anogenital warts

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Anogenital warts whose diagnosis is made based on anamnesis and physical examination, before receiving intralesional purified protein derivative injection therapy.
• 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.

You may not qualify if:

• \. 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.
• \. Have an immunodeficiency disease based on anamnesis and clinical examination, except for HIV based on anamnesis, clinical examination and serological examination (anti-HIV).
• \. Have a history of suffering from malignancy based on history and clinical examination.
• \. Infected with tuberculosis based on history, clinical examination and chest radiography.
• \. 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)).

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Related Publications (1)

• Achdiat 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 BACKGROUND

MeSH Terms

Conditions

Condylomata Acuminata; HIV Infections

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Pati Aji Achdiat, PhD, Dermatovenereologist

CONTACT

+6281322750101; pati.aji.achdiat@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients having anogenital warts will be divided into 2 groups, i.e. HIV and non-HIV groups. Both groups will receive a single injection of tuberculin PPD.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share