Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Completed · Not applicable

Conditions studied: Herpes Simplex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002181

Run by

Gilead Sciences

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Mem Med Group Inc — Long Beach, California, United States
• AIDS Healthcare Foundation Labs — Los Angeles, California, United States
• Sharp Mission Park / Med Group — Oceanside, California, United States
• Park Ctr for Health / Keith Vrhel — San Diego, California, United States
• Potrero Hill Med Ctr — San Francisco, California, United States
• HIV Primary Care & Consult — Santa Rosa, California, United States
• Central Florida Research Initiative — Maitland, Florida, United States
• Braude Mermin Spivey MD PC — Atlanta, Georgia, United States
• Christie Clinic / Urbana Campus — Urbana, Illinois, United States
• Heywood Memorial Hosp — Gardner, Massachusetts, United States
• Gouverneur Hosp — New York, New York, United States
• Central Texas Med Foundation — Austin, Texas, United States
• Dr Nicholaos Bellos — Dallas, Texas, United States
• Dr Susan M Diamond — Dallas, Texas, United States
• ID Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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