GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (PK/GUD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT00808405
First received: November 25, 2008
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Genital Herpes
Drug: acyclovir
Drug: matching placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Time to Healing of Genital Lesions [ Time Frame: Days 1-5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time to First Negative Herpes Simplex Virus (HSV) DNA PCR [ Time Frame: Days 1-5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]
    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


Enrollment: 88
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: acyclovir Drug: acyclovir
400mg taken orally three times daily for 5 days
Placebo Comparator: placebo Drug: matching placebo
matching placebo taken orally three times daily for 5 days.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV negative as determined by concordant rapid testing
  • HSV-2 seropositive (Focus HerpeSelect >3.4)
  • At least one prior occurrence of GUD
  • 18-50 years of age

Exclusion Criteria:

  • Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
  • Prior hypersensitivity &/or allergic reaction to acyclovir
  • Use of probenicid
  • Current use, or use within past 28 days, of an investigational agent
  • Currently pregnant or nursing
  • Currently plan to become pregnant during next 3 months
  • Any condition that will interfere with successful completion of study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808405

Locations
South Africa
Reproductive Health and HIV Research Unit (RHRU)
Johannesburg, South Africa
Zambia
Center for Infectious Disease Research of Zambia (CIDRZ)
Lusaka, Zambia
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Connie Celum, MD, MPH University of Washington
Principal Investigator: Anna Wald, MD, MPH University of Washington
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Celum, MPH/ Principal Investigator, Protocol Co-Chair, University of Washington
ClinicalTrials.gov Identifier: NCT00808405     History of Changes
Other Study ID Numbers: 34708-A, UO1 AI52054
Study First Received: November 25, 2008
Results First Received: April 20, 2012
Last Updated: November 15, 2013
Health Authority: South Africa: Human Research Ethics Committee
United States: Institutional Review Board
Zambia: Research Ethics Committee

Keywords provided by University of Washington:
herpes simplex virus
acyclovir
HSV shedding
women
Africa

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014