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
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Open Label, Safety Study
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
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