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

This study has been completed.
Sponsor:
Collaborator:
ORION Sante
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00761371
First received: September 26, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 26, 2008
September 26, 2008
August 2002
February 2004   (final data collection date for primary outcome measure)
The percentage of subjects with total clearance of initially treated external genital or perianal warts. [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Total clearance [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with a partial reduction of initial wart area; [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Time to achieve reduction in wart area; [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Reduction in wart number [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Appearance of new warts [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • HPV DNA [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • CD4+ lymphocyte and HIV RNA levels [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Warts
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.
Experimental: Imiquimod
Imiquimod 5% cream
Intervention: Drug: Imiquimod 5% cream
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. Epub 2009 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2004
February 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00761371
1456-IMIQ, X-03016-9359000001
Not Provided
Joachim Maus, MD / Director, Clinical Development, Meda Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
ORION Sante
Principal Investigator: Philippe Saiag, MD, Prof. Hospital Ambroise Pare, Department of Dermatology
MEDA Pharma GmbH & Co. KG
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP