Clinical trial NCT00761371: Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Warts
Keywords: external genital and perianal warts
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORION Sante
First posted: 2008-09-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of subjects with total clearance of initially treated external genital or perianal warts.
timeFrame: week 16
Secondary outcomes:
measure: Total clearance
timeFrame: week 16
measure: Percentage of subjects with a partial reduction of initial wart area;
timeFrame: week 16
measure: Time to achieve reduction in wart area;
timeFrame: week 16
measure: Reduction in wart number
timeFrame: week 16
measure: Appearance of new warts
timeFrame: week 16
measure: Recurrence rate
timeFrame: week 16
measure: HPV DNA
timeFrame: week 16
measure: CD4+ lymphocyte and HIV RNA levels
timeFrame: week 16
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Départment de Gynécologie-Obstétrique CHU Saint-Pierre
city: Brussels
country: Belgium
facility: Service de Dermatologie CHU Saint-Pierre
city: Brussels
country: Belgium
facility: Service Dermatologie C.H. François Rabelais (César de Paepe)
city: Brussels
country: Belgium
facility: Service de Dermatologie Hôpital Erasme
city: Besancon Cedex
country: France
facility: Service de Dermatologie et Vénéréologie Hôpital Saint Jacques
city: Bordeaux
country: France
facility: Cabinet Médical
city: Boulogne Billancourt
country: France
facility: Service de Dermatologie, Hôpital Ambroise Paré
city: Marseille
country: France
facility: Service de Maladies Infectieuses Hôpital de la Conception
city: Nantes
country: France
facility: Service de Dermatologie Hôtel Dieu
city: Nice
country: France
facility: Service de Dermatologie Hôpital de l'Archet II
city: Paris
country: France
facility: Service Dermatologie Hopital COCHIN - Pavillon Tarnier
city: Paris
country: France
facility: Cabinet Médical
city: Paris
country: France
facility: Institut Alfred Fournier
city: Paris
country: France
facility: Cabinet Médical
city: Paris
country: France
facility: Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard
city: Paris
country: France
facility: Service de Dermatologie Hopital Tenon
city: Toulouse
country: France
facility: Service de Dermatologie Groupe Hospitalier La Grave
city: Valence
country: France
facility: Service de Dermatologie Centre Hospitalier de Valence
Study officials:
affiliation: Hospital Ambroise Pare, Department of Dermatology
name: Philippe Saiag, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.