CompletedPhase 4

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

Belgium, France52 participantsStarted 2002-08

Plain-language summary

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

Age range18 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 %.

✕. Women pregnant or lactating;
✕. Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:

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

Timeframe: week 16

NCT IDNCT00761371

SponsorMEDA Pharma GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-02