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