SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
NCT ID: NCT00002310
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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The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Detailed Description
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Patients receive 14 days (and up to 42 days) of treatment with topically applied SP-303T. SP-303T is applied directly onto herpes simplex virus lesions three times daily in a quantity sufficient to thinly cover the entire lesion, which may then be covered with an appropriate dressing, if needed. At the end of the treatment period, patients enter a follow-up period of 2 weeks.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Crofelemer
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection.
* AIDS.
* Chronic mucocutaneous herpes simplex virus (HSV) infection, with one or more lesions unresponsive to oral acyclovir therapy.
* No uncontrolled infections other than HSV.
* Sufficient mental status to understand the purpose of the study and to comply with study requirements.
* Sufficient general health to be an outpatient and to come to the clinic for required follow-up visits.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Known hypersensitivity or allergy to citrus fruits, black currant berries, and rose hips.
* Any disease condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, affect patient compliance, or place the patient at increased risk.
Concurrent Medication:
Excluded:
* Other unapproved investigational new drugs.
* Concurrent other therapy for herpes simplex virus (HSV) infection or medications with known activity against HSV.
Required:
* A minimum of 10 days of prior oral acyclovir (at least 1 g daily) or 10 days of prior intravenous acyclovir (15 mg/kg daily).
18 Years
ALL
No
Sponsors
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Shaman Pharmaceuticals
INDUSTRY
Locations
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UCSF - San Francisco Gen Hosp
San Francisco, California, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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SP303T-A-01
Identifier Type: -
Identifier Source: secondary_id
120A
Identifier Type: -
Identifier Source: org_study_id