WartsPhase 4NCT00761371
Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
A Phase 4 study testing Imiquimod 5% cream in people with Warts, run by MEDA Pharma GmbH & Co. KG at 18 sites in 2 countries.
Trial summary
Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Warts
- What is being tested?
- Imiquimod 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Aug 2002to Feb 2004
- Phase
- Phase 4
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject able to understand and willing to give written informed consent.
- Subject ≥ 18 and < 70 years of age.
- Male or female with an HIV infection documented by serology (enzyme linked immunoabsorbent assay (ELISA)), Western Blot assay, or HIV viral load.
- Treated with HAART for at least six months and compliant with the treatment.
- Evidence of efficacy of HAART: total CD4+ lymphocyte counts of ≥ 200 cells/mm3 AND plasma HIV RNA level < 104 RNA copies/mL within four weeks prior to the Treatment Initiation Visit.
- Presence of at least one visible genital or perianal wart as determined by clinical diagnosis.
Show all 17Show fewer
- Total wart area > 10 mm2 and ≤ 4000 mm2 (diameter > 0.4 cm and ≤ 7.1 cm)
- Karnofsky Performance Status ≥ 70 %.
- Accepting to abstain from sexual intercourse when study drug is on the skin.
- In case of a coexisting AIDS-defining illness, both this illness and any treatment being received for it must have been stable for the four weeks preceding enrolment in the trial.
- If female and of childbearing potential, have negative urine pregnancy tests, and willing to use a medically acceptable method of contraception during the 16-week treatment period. Subjects were considered to be of childbearing potential unless the uterus or both ovaries had been removed or they were two or more years postmenopausal. For this study, the following were considered to be acceptable methods of contraception:
- Surgical sterilization, defined as tubal ligation of the subject or a vasectomy of the subject's partner if that subject is in a monogamous heterosexual relationship (at the Investigator's discretion)
- Oral, injectable, or implantable contraceptives
- Condoms (with spermicide)
- Diaphragm/cervical cap (with spermicide)
- Intrauterine devices (IUDs)
- Complete abstinence (at the Investigator's discretion)
Who cannot join
- Women pregnant or lactating;
- Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:
- Any genital wart therapy, or Immunomodulators
- Systemic antiviral drugs other than acyclovir, valacyclovir, or famcyclovir and other than HAART
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France14 sites
Service de Dermatologie et Vénéréologie Hôpital Saint Jacques
Besançon, F-25030
Cabinet Médical
Bordeaux, F-33800
Service de Dermatologie, Hôpital Ambroise Paré
Boulogne-Billancourt, F-92100
Service de Maladies Infectieuses Hôpital de la Conception
Marseille, F-13005
Service de Dermatologie Hôtel Dieu
Nantes, F-44000
Service de Dermatologie Hôpital de l'Archet II
Nice, F-06202
Service Dermatologie Hopital COCHIN - Pavillon Tarnier
Paris, F-75006
Cabinet Médical
Paris, F-75011
Institut Alfred Fournier
Paris, F-75014
Cabinet Médical
Paris, F-75015
Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard
Paris, F-75018
Service de Dermatologie Hopital Tenon
Paris, F-75020
Service de Dermatologie Groupe Hospitalier La Grave
Toulouse, F-31052
Service de Dermatologie Centre Hospitalier de Valence
Valence, F-26000
Belgium4 sites
Départment de Gynécologie-Obstétrique CHU Saint-Pierre
Brussels, B-1000
Service de Dermatologie CHU Saint-Pierre
Brussels, B-1000
Service Dermatologie C.H. François Rabelais (César de Paepe)
Brussels, B-1000
Service de Dermatologie Hôpital Erasme
Brussels, B-1070
About this study
Official title: Exploratory Evaluation of Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients Treated With HAART (CD4+ ≥ 200 Cells mm3): An Open Labeled, Non-comparative Study
Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients
Read the detailed description
To evaluate the percentage of HIV+ subjects successfully treated with HAART, with total clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment with imiquimod 5% cream.
- Conditions
- Warts
- Being tested
- Imiquimod 5% cream
- Keywords
- external genital and perianal warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5% creamDrug
Subjects were treated with imiquimod (one sachet/20 cm2), three applications per week, for up to 16 weeks, or fewer in the case of total clearance of initial warts. At the visit at the end of treatment, a second scraping of the lesion area was carried out to determine the sub-type of HPV.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod | Experimental | Imiquimod 5% cream Receives: Drug: Imiquimod 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with total clearance of initially treated external genital or perianal warts.
Measured: week 16
Secondary outcomes (8)
Total clearance
Measured: week 16
Percentage of subjects with a partial reduction of initial wart area;
Measured: week 16
Time to achieve reduction in wart area;
Measured: week 16
Reduction in wart number
Measured: week 16
Appearance of new warts
Measured: week 16
Recurrence rate
Measured: week 16
HPV DNA
Measured: week 16
CD4+ lymphocyte and HIV RNA levels
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startAug 2002
- Primary completionFeb 2004
- Study completionFeb 2004
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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORION Sante
- Investigators
- Philippe Saiag, MD, Prof., Principal investigator, Hospital Ambroise Pare, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761371
- Sponsor's protocol ID
- 1456-IMIQ
- Other IDs
- X-03016-9359000001
- Status last verified
- Apr 2015
- First submitted
- 26 Sep 2008
- Last updated
- 7 Feb 2022
- Results posted
- No
Publications
Saiag P, Bauhofer A, Bouscarat F, Aquilina C, Ortonne JP, Dupin N, Mougin C. Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study. Br J Dermatol. 2009 Oct;161(4):904-9. doi: 10.1111/j.1365-2133.2009.09210.x. Epub 2009 May 15.
PubMed 19466962
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients Treated With HAART (CD4+ ≥ 200 Cells mm3): An Open Labeled, Non-comparative Study
- ClinicalTrials.gov ID
- NCT00761371
- Acronym / sponsor ID
- 1456-IMIQ
- Conditions
- Warts
- Keywords
- external genital and perianal warts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- ORION Sante
- Study start
- Aug 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 29 Sep 2008 (estimated)
- 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.
Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients
Detailed description
To evaluate the percentage of HIV+ subjects successfully treated with HAART, with total clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment with imiquimod 5% cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imiquimod | Experimental | Drug: Imiquimod 5% creamImiquimod 5% cream |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject able to understand and willing to give written informed consent.
- Subject ≥ 18 and < 70 years of age.
- Male or female with an HIV infection documented by serology (enzyme linked immunoabsorbent assay (ELISA)), Western Blot assay, or HIV viral load.
- Treated with HAART for at least six months and compliant with the treatment.
- Evidence of efficacy of HAART: total CD4+ lymphocyte counts of ≥ 200 cells/mm3 AND plasma HIV RNA level < 104 RNA copies/mL within four weeks prior to the Treatment Initiation Visit.
Key exclusion criteria (4 listed)
- Women pregnant or lactating;
- Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:
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 |
|---|---|---|
| Imiquimod 5% creamSubjects were treated with imiquimod (one sachet/20 cm2), three applications per week, for up to 16 weeks, or fewer in the case of total clearance of initial warts. At the visit at the end of treatment, a second scraping of the lesion area was carried out to determine the sub-type of HPV. | Drug | Imiquimod |
Primary outcome
The percentage of subjects with total clearance of initially treated external genital or perianal warts.
Time frame: week 16
8 secondary outcomes
Total clearance
Time frame: week 16
Percentage of subjects with a partial reduction of initial wart area;
Time frame: week 16
Time to achieve reduction in wart area;
Time frame: week 16
Reduction in wart number
Time frame: week 16
Appearance of new warts
Time frame: week 16
Recurrence rate
Time frame: week 16
HPV DNA
Time frame: week 16
CD4+ lymphocyte and HIV RNA levels
Time frame: week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 19466962Saiag P, Bauhofer A, Bouscarat F, Aquilina C, Ortonne JP, Dupin N, Mougin C. Imiquimod 5% cream for external genital or perianal warts in human immunodeficiency virus-positive patients treated with highly active antiretroviral therapy: an open-label, noncomparative study. Br J Dermatol. 2009 Oct;161(4):904-9. doi: 10.1111/j.1365-2133.2009.09210.x. Epub 2009 May 15.
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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.
Philippe Saiag, MD, Prof. principal investigator
Hospital Ambroise Pare, Department of Dermatology
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod 5% cream in people with Warts, run by MEDA Pharma GmbH & Co. KG at 18 sites in 2 countries.
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 17 inclusion and 4 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: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with total clearance of initially treated external genital or perianal warts. (time frame: week 16). 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 NCT00761371, 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 7 Feb 2022.