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

Phase 4

Completed

• Conditions: Warts
• Interventions: Drug: Imiquimod 5% cream

• Registration Number: NCT00761371
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Status Verified: 2015-04
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imiquimod	Imiquimod 5% cream	Imiquimod 5% cream

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with total clearance of initially treated external genital or perianal warts.	week 16

Secondary Outcome Measures

Name	Time	Method
HPV DNA	week 16
Total clearance	week 16
Percentage of subjects with a partial reduction of initial wart area;	week 16
Time to achieve reduction in wart area;	week 16
Reduction in wart number	week 16
Appearance of new warts	week 16
Recurrence rate	week 16
CD4+ lymphocyte and HIV RNA levels	week 16

Trial Locations

Locations (16)

Service de Dermatologie Hôpital Erasme; 🇧🇪 Brussels, Belgium

Service Dermatologie Hopital COCHIN - Pavillon Tarnier; 🇫🇷 Paris, France

Institut Alfred Fournier; 🇫🇷 Paris, France

Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard; 🇫🇷 Paris, France

Départment de Gynécologie-Obstétrique CHU Saint-Pierre; 🇧🇪 Brussels, Belgium

Service de Dermatologie, Hôpital Ambroise Paré; 🇫🇷 Boulogne Billancourt, France

Service de Dermatologie Hôtel Dieu; 🇫🇷 Nantes, France

Service de Dermatologie Hôpital de l'Archet II; 🇫🇷 Nice, France

Service de Dermatologie Groupe Hospitalier La Grave; 🇫🇷 Toulouse, France

Service de Maladies Infectieuses Hôpital de la Conception; 🇫🇷 Marseille, France

Service de Dermatologie CHU Saint-Pierre; 🇧🇪 Brussels, Belgium

Service de Dermatologie Hopital Tenon; 🇫🇷 Paris, France

Service Dermatologie C.H. François Rabelais (César de Paepe); 🇧🇪 Brussels, Belgium

Service de Dermatologie Centre Hospitalier de Valence; 🇫🇷 Valence, France

Cabinet Médical; 🇫🇷 Paris, France

Service de Dermatologie et Vénéréologie Hôpital Saint Jacques; 🇫🇷 Besancon Cedex, France