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Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Cidofovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Gilead Sciences

Summary

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Detailed description: Patients receive open-label treatment with cidofovir gel.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Mem Med Group Inc, Long Beach, California 90806, United States

AIDS Healthcare Foundation Labs, Los Angeles, California 90027, United States

Sharp Mission Park / Med Group, Oceanside, California 92054, United States

Park Ctr for Health / Keith Vrhel, San Diego, California 92103, United States

Potrero Hill Med Ctr, San Francisco, California 94107, United States

HIV Primary Care & Consult, Santa Rosa, California 95404, United States

Central Florida Research Initiative, Maitland, Florida 32751, United States

Braude Mermin Spivey MD PC, Atlanta, Georgia 30309, United States

Christie Clinic / Urbana Campus, Urbana, Illinois 61801, United States

Heywood Memorial Hosp, Gardner, Massachusetts 01440, United States

Gouverneur Hosp, New York, New York 10002, United States

Central Texas Med Foundation, Austin, Texas 78751, United States

Dr Nicholaos Bellos, Dallas, Texas 75225, United States

Dr Susan M Diamond, Dallas, Texas 75225, United States

ID Associates, Dallas, Texas 75231, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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