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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15-60
SponsorUniversitas Padjadjaran

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injection of protein purified derivative

    Other intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: HIV-positive patients with anogenital wartsExperimental treatment 1 intervention
Group B: HIV-negative patients with anogenital wartsExperimental treatment 1 intervention

Trial outcomes

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

Time frame
3 weeks after treatment

Secondary outcomes

1

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

Time frame
3 weeks after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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