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 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.

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).