Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
Completed
Shaman Pharmaceuticals
N/A
1969-12-31
To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303
gel in combination with acyclovir, relative to acyclovir alone, for the treatment of
recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and
neighboring areas, in patients with AIDS.
SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
Completed
Shaman Pharmaceuticals
N/A
1969-12-31
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.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
Completed
Shaman Pharmaceuticals
Phase 3
1969-12-31
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool
weight in AIDS patients with diarrhea over 6 days of treatment.
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