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

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ClinicalTrials.gov Identifier: NCT00808405
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 18, 2012
Last Update Posted : December 11, 2013
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Connie Celum, University of Washington

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE December 15, 2008
Results First Submitted Date  ICMJE April 20, 2012
Results First Posted Date  ICMJE May 18, 2012
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
Time to Healing of Genital Lesions [ Time Frame: Days 1-5, 7, 9, 11, 13 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
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 ]
Change History Complete list of historical versions of study NCT00808405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR [ Time Frame: Days 1-5, 7, 9, 11, 13 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Official Title  ICMJE Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes
Intervention  ICMJE
  • Drug: acyclovir
    400mg taken orally three times daily for 5 days
  • Drug: matching placebo
    matching placebo taken orally three times daily for 5 days.
Study Arms  ICMJE
  • Active Comparator: acyclovir
    Intervention: Drug: acyclovir
  • Placebo Comparator: placebo
    Intervention: Drug: matching placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2012)
88
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
150
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Zambia
Removed Location Countries Zimbabwe
 
Administrative Information
NCT Number  ICMJE NCT00808405
Other Study ID Numbers  ICMJE 34708-A
U01AI052054 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Celum, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Connie Celum, MD, MPH University of Washington
Principal Investigator: Anna Wald, MD, MPH University of Washington
PRS Account University of Washington
Verification Date November 2013

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