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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Crofelemer (Drug)

Phase: N/A

Status: Completed

Sponsored by: Shaman Pharmaceuticals

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.

Clinical Details

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

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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States

TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida 33308, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States

Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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