MedTrace Logo

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

NCT00808405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2013-12-11

Study results available
· View outcomes & findings →

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

DRUG

acyclovir

400mg taken orally three times daily for 5 days

DRUG

matching placebo

matching placebo taken orally three times daily for 5 days.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Connie Celum, MD, MPH · University of Washington

  • Anna Wald, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2010-07-31

Countries

  • South Africa
  • Zambia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808405 on ClinicalTrials.gov