Anogenital WartsPhase 2/3NCT06587542
Effectivity of Protein Purified Derivative Treatment for Anogenital Warts in HIV Patient
A Phase 2/3 study testing Injection of protein purified derivative in people with Anogenital Warts and HIV Infection, run by Universitas Padjadjaran.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Anogenital Warts, HIV Infection, Tuberculin Purified Protein Derivative
- What is being tested?
- Injection of protein purified derivative
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 31 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Injection of protein purified derivative
- Keywords
- anogenital warts, HIV infection, tuberculin purified protein derivative
- Medical subject headings
- Condylomata Acuminata, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of protein purified derivativeOther
Injection of purified protein derivative for anogenital warts in HIV and non HIV patient, on the largest lesion
| Study group | Role | What they receive |
|---|---|---|
| HIV-positive patients with anogenital warts | Experimental | Injection of protein purified derivative Receives: Other: Injection of protein purified derivative |
| HIV-negative patients with anogenital warts | Experimental | Not described Receives: Other: Injection of protein purified derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anogenital WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587542
- Sponsor's protocol ID
- DV-202407.01
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Its need the Indonesian goverment clearance for do so
Publications
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.
PubMed 39635572
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Response and Pathomechanism of Purified Tuberculin Unit Protein Injection Therapy for Anogenital Warts with and Without HIV Infection
- ClinicalTrials.gov ID
- NCT06587542
- Acronym / sponsor ID
- DV-202407.01
- Keywords
- anogenital warts, HIV infection, tuberculin purified protein derivative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HIV-positive patients with anogenital warts | Experimental | Other: Injection of protein purified derivativeInjection of protein purified derivative |
| HIV-negative patients with anogenital warts | Experimental | Other: Injection of protein purified derivative |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of protein purified derivativeInjection of purified protein derivative for anogenital warts in HIV and non HIV patient, on the largest lesion | Other | HIV-negative patients with anogenital warts, HIV-positive patients with anogenital warts |
Primary outcome
clinical improvement
Time frame: 3 weeks after treatment
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
1 secondary outcome
cytokine change in blood and tissue
Time frame: 3 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 39635572Achdiat 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.
- Individual participant dataSharing planned: No. Its need the Indonesian goverment clearance for do so
Related trials for Anogenital Warts
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Injection of protein purified derivative in people with Anogenital Warts and HIV Infection, run by Universitas Padjadjaran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pati Aji Achdiat, PhD, Dermatovenereologist (+6281322750101, pati.aji.achdiat@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement (time frame: 3 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.