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NCT00002181 Clinical Trial

Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002181
Other study ID # 218B
Secondary ID GS-96-307
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date November 1997
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

Patients receive open-label treatment with cidofovir gel.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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).

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cidofovir

Locations
Country Name City State
United States Braude Mermin Spivey MD PC Atlanta Georgia
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 Heywood Memorial Hosp Gardner Massachusetts
United States Mem Med Group Inc Long Beach California
United States AIDS Healthcare Foundation Labs Los Angeles California
United States Central Florida Research Initiative Maitland Florida
United States Gouverneur Hosp New York New York
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 Christie Clinic / Urbana Campus Urbana Illinois

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

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