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)
NCT00002186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2005-06-24
Summary
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.
Conditions
- Herpes Simplex
- HIV Infections
Interventions
- DRUG
-
Crofelemer
- DRUG
-
Acyclovir
Sponsors & Collaborators
-
Shaman Pharmaceuticals
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
- Puerto Rico
Study Locations
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