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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
NCT00761371 |
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Date of registration:
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26/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
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Scientific title:
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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 |
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Date of first enrolment:
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August 2002 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00761371 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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France
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Contacts
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Name:
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Philippe Saiag, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Ambroise Pare, Department of Dermatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Warts
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Intervention(s)
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Drug: Imiquimod 5% cream
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Primary Outcome(s)
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The percentage of subjects with total clearance of initially treated external genital or perianal warts.
[Time Frame: week 16]
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Secondary Outcome(s)
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Reduction in wart number
[Time Frame: week 16]
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CD4+ lymphocyte and HIV RNA levels
[Time Frame: week 16]
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HPV DNA
[Time Frame: week 16]
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Appearance of new warts
[Time Frame: week 16]
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Total clearance
[Time Frame: week 16]
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Time to achieve reduction in wart area;
[Time Frame: week 16]
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Recurrence rate
[Time Frame: week 16]
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Percentage of subjects with a partial reduction of initial wart area;
[Time Frame: week 16]
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Secondary ID(s)
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X-03016-9359000001
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1456-IMIQ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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