Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
NCT ID: NCT00002181
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Cidofovir
Eligibility Criteria
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Inclusion Criteria
* 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
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).
13 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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GS-96-307
Identifier Type: -
Identifier Source: secondary_id
218B
Identifier Type: -
Identifier Source: org_study_id