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

Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761371
• Other study ID #: 1456-IMIQ
• Secondary ID: X-03016-93590000
• Status: Completed
• Phase: Phase 4
• Start date: August 2002
• Est. completion date: February 2004

Study information

• Verified date: April 2015
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Warts

Intervention

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.

Locations

Country	Name	City	State
Belgium	Départment de Gynécologie-Obstétrique CHU Saint-Pierre	Brussels
Belgium	Service de Dermatologie CHU Saint-Pierre	Brussels
Belgium	Service de Dermatologie Hôpital Erasme	Brussels
Belgium	Service Dermatologie C.H. François Rabelais (César de Paepe)	Brussels
France	Service de Dermatologie et Vénéréologie Hôpital Saint Jacques	Besancon Cedex
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	Cabinet Médical	Paris
France	Cabinet Médical	Paris
France	Institut Alfred Fournier	Paris
France	Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard	Paris
France	Service de Dermatologie Hopital Tenon	Paris
France	Service Dermatologie Hopital COCHIN - Pavillon Tarnier	Paris
France	Service de Dermatologie Groupe Hospitalier La Grave	Toulouse
France	Service de Dermatologie Centre Hospitalier de Valence	Valence

Sponsors (2)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG	ORION Sante

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects with total clearance of initially treated external genital or perianal warts.		week 16
Secondary	Total clearance		week 16
Secondary	Percentage of subjects with a partial reduction of initial wart area;		week 16
Secondary	Time to achieve reduction in wart area;		week 16
Secondary	Reduction in wart number		week 16
Secondary	Appearance of new warts		week 16
Secondary	Recurrence rate		week 16
Secondary	HPV DNA		week 16
Secondary	CD4+ lymphocyte and HIV RNA levels		week 16