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

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

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

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.

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