Clinical Trials

MainTitle

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

This study has been completed
Sponsor
MEDA Pharma GmbH & Co. KG

Collaborator
ORION Sante

Information provided by (Responsible Party)
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier
NCT00761371

First received: September 26, 2008
Last updated: April 9, 2015
Last Verified: April 2015
History of Changes
Purpose

Purpose

Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

Condition Intervention Phase
Warts

Drug : Imiquimod 5% cream
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures

  • The percentage of subjects with total clearance of initially treated external genital or perianal warts. [ Time Frame: week 16 ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: August 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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

Eligibility

Ages Eligible for Study: 18 Years to 69 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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:
  • 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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00761371

    Locations

    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

    Sponsors and Collaborators

    MEDA Pharma GmbH & Co. KG
    ORION Sante

    Investigators

    Principal Investigator: Philippe Saiag, MD, Prof. Hospital Ambroise Pare, Department of Dermatology
    More Information

    More Information


    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  
    Study First Received: September 26, 2008  
    Last Updated: April 9, 2015  

    Keywords provided by MEDA Pharma GmbH & Co. KG:

    external genital and perianal warts

    Additional relevant MeSH terms:
    Warts
    Imiquimod

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.