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

HIV Infections Clinical Trial

Official title:

A Pilot Study to Determine the Safety and Efficacy of Topically Applied SP-303T in Patients With Acquired Immunodeficiency Syndrome and Concomitant Herpes Simplex Virus (HSV) Infection Unresponsive to Acyclovir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002310
• Other study ID #: 120A
• Secondary ID: SP303T-A-01
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy.

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Herpes Simplex
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Crofelemer

Locations

Country	Name	City	State
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	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Shaman Pharmaceuticals

Country where clinical trial is conducted

United States,