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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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:

  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
  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
Service de Dermatologie Hôpital Erasme
Brussels, Belgium, B-1070
Service de Dermatologie CHU Saint-Pierre
Brussels, Belgium, B-1000
Départment de Gynécologie-Obstétrique CHU Saint-Pierre
Brussels, Belgium, B-1000
Service Dermatologie C.H. François Rabelais (César de Paepe)
Brussels, Belgium, B-1000
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
Cabinet Médical
Paris, France, F-75011
Service de Dermatologie Hopital Tenon
Paris, France, F-75020
Cabinet Médical
Paris, France, F-75015
Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard
Paris, France, F-75018
Service Dermatologie Hopital COCHIN - Pavillon Tarnier
Paris, France, F-75006
Institut Alfred Fournier
Paris, France, F-75014
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

No publications provided by MEDA Pharma GmbH & Co. KG

Additional 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
Study First Received: September 26, 2008
Last Updated: September 26, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 30, 2014