Status:
COMPLETED
Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Collaborating Sponsors:
ORION Sante
Conditions:
Warts
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
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% c...
Eligibility Criteria
Inclusion
- 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)
- Intrauterine devices (IUDs)
- Complete abstinence (at the Investigator's discretion)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00761371
Start Date
August 1 2002
End Date
February 1 2004
Last Update
February 7 2022
Active Locations (18)
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1
Départment de Gynécologie-Obstétrique CHU Saint-Pierre
Brussels, Belgium, B-1000
2
Service de Dermatologie CHU Saint-Pierre
Brussels, Belgium, B-1000
3
Service Dermatologie C.H. François Rabelais (César de Paepe)
Brussels, Belgium, B-1000
4
Service de Dermatologie Hôpital Erasme
Brussels, Belgium, B-1070