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.
2 other identifiers
interventional
N/A
1 country
15
Brief 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.
Trial Health
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15 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (15)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-11