SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
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
2 other identifiers
interventional
N/A
1 country
4
Brief 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.
Trial Health
Trial Health Score
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4 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
September 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1993-09