Clinical Trial: GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Brief Summary: To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome: Time to Healing of Genital Lesions [ Time Frame: Days 1-5, 7, 9, 11, 13 ]

To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo


Original Primary Outcome: To measure Area Under the Curve (AUC) from a single dose of acyclovir 400 mg orally in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease(GUD), are HSV-2 seropositive. [ Time Frame: 0, 1,2, 4, 6, 8 hours post-dose ]

Current Secondary Outcome: Time to First Negative Herpes Simplex Virus (HSV) DNA PCR [ Time Frame: Days 1-5, 7, 9, 11, 13 ]

To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo


Original Secondary Outcome: To examine the time to healing of genital lesions and duration of HSV shedding from GUD among women who have a history of GUD and are HSV-2 seropostive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo. [ Time Frame: Healing and shedding assessed days 1-5, 7, 9, 11, 13 ]

Information By: University of Washington

Dates:
Date Received: November 25, 2008
Date Started: January 2009
Date Completion:
Last Updated: November 15, 2013
Last Verified: November 2013