Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
MEDA Pharma GmbH & Co. KG ORION Sante |
---|---|
Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00761371 |
Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients
Condition | Intervention | Phase |
---|---|---|
Warts |
Drug: Imiquimod 5% cream |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
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 |
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 |
---|---|
Imiquimod: Experimental
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.
|
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.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:
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, Hôpital Ambroise Paré | |
Boulogne Billancourt, France, F-92100 | |
Service de Dermatologie Hôtel Dieu | |
Nantes, France, F-44000 | |
Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard | |
Paris, France, F-75018 | |
Service de Dermatologie Groupe Hospitalier La Grave | |
Toulouse, France, F-31052 | |
Service de Dermatologie Hopital Tenon | |
Paris, France, F-75020 | |
Cabinet Médical | |
Paris, France, F-75015 | |
Cabinet Médical | |
Bordeaux, France, F-33800 | |
Service de Dermatologie et Vénéréologie Hôpital Saint Jacques | |
Besancon Cedex, France, F-25030 | |
Service de Dermatologie Centre Hospitalier de Valence | |
Valence, France, F-26000 | |
Service de Maladies Infectieuses Hôpital de la Conception | |
Marseille, France, F-13005 | |
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 |
Principal Investigator: | Philippe Saiag, MD, Prof. | Hospital Ambroise Pare, Department of Dermatology |
Responsible Party: | Meda Pharma GmbH & Co. KG ( Joachim Maus, MD / Director, Clinical Development ) |
Study ID Numbers: | 1456-IMIQ, X-03016-9359000001 |
Study First Received: | September 26, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00761371 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
external genital and perianal warts |
Virus Diseases Skin Diseases, Infectious Warts Skin Diseases HIV Infections |
Interferons Acquired Immunodeficiency Syndrome Imiquimod DNA Virus Infections Papillomavirus Infections |
Skin Diseases, Viral Interferon Inducers Neoplasms Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Tumor Virus Infections Pharmacologic Actions |