Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients

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

Study Overview

• Status: Completed
• Conditions: Warts
• Intervention / Treatment: Drug: Imiquimod 5% cream

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1000
    • 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-1070
    • Service de Dermatologie Hôpital Erasme
• France
  • Besancon Cedex, France, F-25030
    • Service de Dermatologie et Vénéréologie Hôpital Saint Jacques
  • Bordeaux, France, F-33800
    • Cabinet Medical
  • Boulogne Billancourt, France, F-92100
    • Service de Dermatologie, Hôpital Ambroise Paré
  • Marseille, France, F-13005
    • Service de Maladies Infectieuses Hôpital de la Conception
  • Nantes, France, F-44000
    • Service de Dermatologie Hôtel Dieu
  • Nice, France, F-06202
    • Service de Dermatologie Hôpital de l'Archet II
  • Paris, France, F-75006
    • Service Dermatologie Hopital COCHIN - Pavillon Tarnier
  • Paris, France, F-75011
    • Cabinet Medical
  • Paris, France, F-75014
    • Institut Alfred Fournier
  • Paris, France, F-75015
    • Cabinet Medical
  • Paris, France, F-75018
    • Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard
  • Paris, France, F-75020
    • Service de Dermatologie Hopital Tenon
  • Toulouse, France, F-31052
    • Service de Dermatologie Groupe Hospitalier La Grave
  • Valence, France, F-26000
    • Service de Dermatologie Centre Hospitalier de Valence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject able to understand and willing to give written informed consent.
2. Subject ≥ 18 and < 70 years of age.
3. Male or female with an HIV infection documented by serology (enzyme linked immunoabsorbent assay (ELISA)), Western Blot assay, or HIV viral load.
4. Treated with HAART for at least six months and compliant with the treatment.
5. 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.
6. Presence of at least one visible genital or perianal wart as determined by clinical diagnosis.
7. Total wart area > 10 mm2 and ≤ 4000 mm2 (diameter > 0.4 cm and ≤ 7.1 cm)
8. Karnofsky Performance Status ≥ 70 %.
9. Accepting to abstain from sexual intercourse when study drug is on the skin.
10. 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.

11. 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:

1. Women pregnant or lactating;

2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects with total clearance of initially treated external genital or perianal warts.	week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Total clearance	week 16
Percentage of subjects with a partial reduction of initial wart area;	week 16
Time to achieve reduction in wart area;	week 16
Reduction in wart number	week 16
Appearance of new warts	week 16
Recurrence rate	week 16
HPV DNA	week 16
CD4+ lymphocyte and HIV RNA levels	week 16

Collaborators and Investigators

• Sponsor: MEDA Pharma GmbH & Co. KG
• Collaborators: ORION Sante
• Investigators: Principal Investigator: Philippe Saiag, MD, Prof., Hospital Ambroise Pare, Department of Dermatology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 29, 2008

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: external genital and perianal warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: 1456-IMIQ; X-03016-9359000001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No