Orozco-Topete R, et al. Safety and Efficacy of Virend for Topical Treatment of Genital and Anal Herpes Simplex Lesions in Patients with AIDS. Antiviral Research 1997; 35: 91-103.
A multicenter, double-blind, placebo-controlled study found that a topical preparation containing 15% SP-303 was no more effective than placebo in treating recurrent genital herpes lesions in AIDS patients. Of the 45 patients recruited for this study, 24 were randomly assigned to the treatment group and 21 to the placebo group. At the end of the study, there was a higher percentage of patients in the treatment group whose lesions had completely healed as compared to the placebo group. However, these results were not statistically significant (P = 0.079). Several patients withdrew from this study (for a variety of reasons that included experiencing a burning sensation at the site of application, advancing HIV disease, and death.)
Holodniy M, et al. A Double Blind, Randomized, Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of Orally Administered SP-303 for the Symptomatic Treatment of Diarrhea in Patients with AIDS. Am J Gastroenterology 1999; 94 (11): 3267-3273.
A multicenter, phase II, double-blind, placebo-controlled study found that oral administration of SP-303 may be effective in the treatment of diarrhea in AIDS patients. Fifty-one patients were randomized to receive either a 500 mg oral tablet of SP-303 or placebo every 6 hours over the course of 4 days. Using a daily measures analysis over the four days of treatment, the authors demonstrated that patients who received SP-303 tablets had a significant reduction in stool weight (p = 0.008), as well as a reduction in abnormal stool frequency (p = 0.04) when compared to those who received placebo. The authors report that oral administration of SP-303 seems to be safe and well tolerated.
DiCesare D, et al. A Double Blind, Randomized, Placebo-Controlled Study of SP-303 (Provir) in the Symptomatic Treatment of Acute Diarrhea Among Travelers to Jamaica and Mexico. Am J Gastroenterology 2002; 97(10): 2585-2588.
A double blind, randomized, placebo-controlled study found that oral administration of SP-303 may be effective in the treatment of travelers' diarrhea. A total of 184 patients were recruited for this study who had all traveled to Mexico or Jamaica and presented with a clinical history of abrupt onset non bloody diarrhea of a duration of 48 hours or less. The participants were randomly assigned to 1 of 4 treatment groups that were given tablets containing either 125 mg SP-303, 250 mg SP-303, 500 mg SP-303, or placebo. Participants were instructed to take the tablets four times a day for a total of two days. The authors found that oral administration of SP-303 was effective in shortening the duration of travelers' diarrhea by 21%. In addition, the authors also reported a partial or complete improvement of symptoms on day 1 in the treatment group.