Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Open Label
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
AIDS Healthcare Foundation Labs, Los Angeles, California 90027, United States
Potrero Hill Med Ctr, San Francisco, California 94107, United States
Mem Med Group Inc, Long Beach, California 90806, United States
Park Ctr for Health / Keith Vrhel, San Diego, California 92103, United States
HIV Primary Care & Consult, Santa Rosa, California 95404, United States
Sharp Mission Park / Med Group, Oceanside, California 92054, 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
|
