NCT00761371

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2002

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
Last Updated

February 7, 2022

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

September 26, 2008

Last Update Submit

February 4, 2022

Conditions

Warts

Keywords

external genital and perianal warts

Outcome Measures

Primary Outcomes (1)

  • The percentage of subjects with total clearance of initially treated external genital or perianal warts.

    week 16

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Imiquimod

EXPERIMENTAL

Imiquimod 5% cream

Drug: Imiquimod 5% cream

Interventions

Imiquimod 5% creamDRUG

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.

Imiquimod

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject able to understand and willing to give written informed consent.
  • Subject ≥ 18 and \< 70 years of age.
  • Male or female with an HIV infection documented by serology (enzyme linked immunoabsorbent assay (ELISA)), Western Blot assay, or HIV viral load.
  • Treated with HAART for at least six months and compliant with the treatment.
  • 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.
  • Presence of at least one visible genital or perianal wart as determined by clinical diagnosis.
  • Total wart area \> 10 mm2 and ≤ 4000 mm2 (diameter \> 0.4 cm and ≤ 7.1 cm)
  • Karnofsky Performance Status ≥ 70 %.
  • Accepting to abstain from sexual intercourse when study drug is on the skin.
  • 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.
  • 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)
  • +2 more criteria

You may not qualify if:

  • Women pregnant or lactating;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Départment de Gynécologie-Obstétrique CHU Saint-Pierre

Brussels, B-1000, Belgium

Location

Service de Dermatologie CHU Saint-Pierre

Brussels, B-1000, Belgium

Location

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

Brussels, B-1000, Belgium

Location

Service de Dermatologie Hôpital Erasme

Brussels, B-1070, Belgium

Location

Service de Dermatologie et Vénéréologie Hôpital Saint Jacques

Besançon, F-25030, France

Location

Cabinet Médical

Bordeaux, F-33800, France

Location

Service de Dermatologie, Hôpital Ambroise Paré

Boulogne-Billancourt, F-92100, France

Location

Service de Maladies Infectieuses Hôpital de la Conception

Marseille, F-13005, France

Location

Service de Dermatologie Hôtel Dieu

Nantes, F-44000, France

Location

Service de Dermatologie Hôpital de l'Archet II

Nice, F-06202, France

Location

Service Dermatologie Hopital COCHIN - Pavillon Tarnier

Paris, F-75006, France

Location

Cabinet Médical

Paris, F-75011, France

Location

Institut Alfred Fournier

Paris, F-75014, France

Location

Cabinet Médical

Paris, F-75015, France

Location

Service de Dermatologie Groupe Hospitalier Bichat Claude Bernard

Paris, F-75018, France

Location

Service de Dermatologie Hopital Tenon

Paris, F-75020, France

Location

Service de Dermatologie Groupe Hospitalier La Grave

Toulouse, F-31052, France

Location

Service de Dermatologie Centre Hospitalier de Valence

Valence, F-26000, France

Location

Related Publications (1)

  • 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.

    PMID: 19466962DERIVED

MeSH Terms

Conditions

Warts

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Philippe Saiag, MD, Prof.

    Hospital Ambroise Pare, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

August 1, 2002

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

February 7, 2022

Record last verified: 2015-04

Locations

BE(4)FR(14)