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

NCT ID: NCT00761371

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2004-02-29

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.

Conditions

Warts

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imiquimod

Imiquimod 5% cream

Group Type: EXPERIMENTAL

Imiquimod 5% cream

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORION Sante

UNKNOWN

Sponsor Role: collaborator

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Meda Pharma GmbH & Co. KG

Principal Investigators

Philippe Saiag, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hospital Ambroise Pare, Department of Dermatology

Locations

Départment de Gynécologie-Obstétrique CHU Saint-Pierre

Brussels, , Belgium

Service de Dermatologie CHU Saint-Pierre

Brussels, , Belgium

Service Dermatologie C.H. François Rabelais (César de Paepe)

Brussels, , Belgium

Service de Dermatologie Hôpital Erasme

Brussels, , Belgium

Service de Dermatologie et Vénéréologie Hôpital Saint Jacques

Besançon, , France

Cabinet Médical

Bordeaux, , France

Service de Dermatologie, Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Service de Maladies Infectieuses Hôpital de la Conception

Marseille, , France

Service de Dermatologie Hôtel Dieu

Nantes, , France

Service de Dermatologie Hôpital de l'Archet II

Nice, , France

Service Dermatologie Hopital COCHIN - Pavillon Tarnier

Paris, , France

Cabinet Médical

Paris, , France

Institut Alfred Fournier

Paris, , France

Cabinet Médical

Paris, , France

Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard

Paris, , France

Service de Dermatologie Hopital Tenon

Paris, , France

Service de Dermatologie Groupe Hospitalier La Grave

Toulouse, , France

Service de Dermatologie Centre Hospitalier de Valence

Valence, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 19466962 (View on PubMed)

Other Identifiers

X-03016-9359000001

Identifier Type: -

Identifier Source: secondary_id

1456-IMIQ

Identifier Type: -

Identifier Source: org_study_id