Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
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ClinicalTrials.gov Identifier: NCT00761371 |
Recruitment Status
:
Completed
First Posted
: September 29, 2008
Last Update Posted
: April 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Warts | Drug: Imiquimod 5% cream | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | February 2004 |
Actual Study Completion Date : | February 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Imiquimod
Imiquimod 5% cream
|
Drug: Imiquimod 5% cream
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.
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- The percentage of subjects with total clearance of initially treated external genital or perianal warts. [ Time Frame: week 16 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
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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)
Exclusion Criteria:
- Women pregnant or lactating;
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761371
Belgium | |
Départment de Gynécologie-Obstétrique CHU Saint-Pierre | |
Brussels, Belgium, B-1000 | |
Service de Dermatologie CHU Saint-Pierre | |
Brussels, Belgium, B-1000 | |
Service Dermatologie C.H. François Rabelais (César de Paepe) | |
Brussels, Belgium, B-1000 | |
Service de Dermatologie Hôpital Erasme | |
Brussels, Belgium, B-1070 | |
France | |
Service de Dermatologie et Vénéréologie Hôpital Saint Jacques | |
Besancon Cedex, France, F-25030 | |
Cabinet Médical | |
Bordeaux, France, F-33800 | |
Service de Dermatologie, Hôpital Ambroise Paré | |
Boulogne Billancourt, France, F-92100 | |
Service de Maladies Infectieuses Hôpital de la Conception | |
Marseille, France, F-13005 | |
Service de Dermatologie Hôtel Dieu | |
Nantes, France, F-44000 | |
Service de Dermatologie Hôpital de l'Archet II | |
Nice, France, F-06202 | |
Service Dermatologie Hopital COCHIN - Pavillon Tarnier | |
Paris, France, F-75006 | |
Cabinet Médical | |
Paris, France, F-75011 | |
Institut Alfred Fournier | |
Paris, France, F-75014 | |
Cabinet Médical | |
Paris, France, F-75015 | |
Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard | |
Paris, France, F-75018 | |
Service de Dermatologie Hopital Tenon | |
Paris, France, F-75020 | |
Service de Dermatologie Groupe Hospitalier La Grave | |
Toulouse, France, F-31052 | |
Service de Dermatologie Centre Hospitalier de Valence | |
Valence, France, F-26000 |
Principal Investigator: | Philippe Saiag, MD, Prof. | Hospital Ambroise Pare, Department of Dermatology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Joachim Maus, MD / Director, Clinical Development, Meda Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00761371 History of Changes |
Other Study ID Numbers: |
1456-IMIQ X-03016-9359000001 |
First Posted: | September 29, 2008 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | April 2015 |
Keywords provided by MEDA Pharma GmbH & Co. KG:
external genital and perianal warts |
Additional relevant MeSH terms:
Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious |
Skin Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |