Warts
Conditions
Keywords
external genital and perianal warts
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.
Interventions
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.
Sponsors
ORION Sante
MEDA Pharma GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with total clearance of initially treated external genital or perianal warts. | week 16 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| HPV DNA | week 16 |
| CD4+ lymphocyte and HIV RNA levels | week 16 |
Countries
Belgium, France
Outcome results
None listed