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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCSF - San Francisco Gen Hosp
San Francisco, California, 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
Last Updated
June 24, 2005
Crofelemer
DRUG
Lead Sponsor
Shaman Pharmaceuticals
NCT06694805
NCT04142047
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View ClinicalTrials.gov Terms and ConditionsNCT07428330