SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

Launched by SHAMAN PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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.

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 su...

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Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • 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
• Co-existing Condition:
• 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).