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

November 25, 2008
November 15, 2013
January 2009
December 2009   (final data collection date for primary outcome measure)
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
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00808405 on ClinicalTrials.gov Archive Site
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
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Genital Herpes
  • Drug: acyclovir
    400mg taken orally three times daily for 5 days
  • Drug: matching placebo
    matching placebo taken orally three times daily for 5 days.
  • Active Comparator: acyclovir
    Intervention: Drug: acyclovir
  • Placebo Comparator: placebo
    Intervention: Drug: matching placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
July 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa,   Zambia
 
NCT00808405
34708-A, UO1 AI52054
No
Connie Celum, University of Washington
University of Washington
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
Principal Investigator: Connie Celum, MD, MPH University of Washington
Principal Investigator: Anna Wald, MD, MPH University of Washington
University of Washington
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP