CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
acyclovir +1 moredrug
Likely dose
acyclovir 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00808405
NCT00808405N/ACompleted
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Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

University of Washington·interventional·Posted Dec 15, 2008·Updated Dec 11, 2013

In Brief

A clinical study evaluating acyclovir and matching placebo for Genital Herpes. Completed, enrolled 88 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Herpes
CountriesSouth Africa, Zambia
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2008
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.5 years ago

Interventions

acyclovirdrug

400mg taken orally three times daily for 5 days

matching placebodrug

matching placebo taken orally three times daily for 5 days.