Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.

The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.

Patients receive open-label treatment with cidofovir gel.

Inclusion Criteria

Patients must have:

• AIDS diagnosis per CDC criteria.
• At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
• Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
• Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).

Concurrent Medication:

Excluded:

Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.

Required:

>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).