NCT00808405

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Genital Herpes

Interventions

Type	Name	Description
DRUG	acyclovir	400mg taken orally three times daily for 5 days
DRUG	matching placebo	matching placebo taken orally three times daily for 5 days.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2008-12-15
• Last updated: 2013-12-11
• Results posted: 2012-05-18

Locations

2 sites across 2 countries: South Africa, Zambia