Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stewart Reid, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02053142
First received: January 31, 2014
Last updated: February 6, 2014
Last verified: February 2014

January 31, 2014
February 6, 2014
January 2009
December 2009   (final data collection date for primary outcome measure)
Area under the Curve (AUC) [ Time Frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration ] [ Designated as safety issue: No ]
Blood will be drawn for pharmacokinetic measures to determine whether there is a difference in African women vs. the existing AUC data for women and men in North America and Europe.
Same as current
Complete list of historical versions of study NCT02053142 on ClinicalTrials.gov Archive Site
Time to re-epithelization and time to cessation of HSV shedding [ Time Frame: days 1-5, 7, 9, 11 and 13 ] [ Designated as safety issue: No ]
Daily assessment of response of genital lesions over 13 days by time to healing and duration of HSV shedding during acyclovir 400mg orally three times daily versus placebo three times daily for 5 days.
Same as current
Not Provided
Not Provided
 
Acyclovir Therapy for Genital Herpes Ulcers 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

This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.

This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative. The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcers of Female Genital Organs
  • Drug: Acyclovir
    Single dose of acyclovir 200mg was given for pk study
  • Drug: Placebo
  • Experimental: Part 1 PK
    400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
    Intervention: Drug: Acyclovir
  • Active Comparator: Acyclovir
    400 mg Acyclovir three times daily for 5 days
    Intervention: Drug: Acyclovir
  • Placebo Comparator: Placebo
    Placebo three times daily for 5 days
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
December 2009
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 EIA >3.4)
  • At least one prior occurrence of GUD
  • 18 to 50 years of age

Exclusion Criteria:

  • Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
  • Prior hypersensitivity and/or allergic reaction to acyclovir
  • Use of probenecid, which prolongs renal excretion of acyclovir
  • Current use, or use within the past 28 days, of an investigational agent
  • Currently pregnant or nursing
  • Currently plan to become pregnant during the next 3 months
  • Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
  • Current use of more than 20 cigarettes daily (for Part I)
  • Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT02053142
12-0390
No
Stewart Reid, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Stewart Reid, MD Centre for Infectious Disease Research in Zambia
University of North Carolina, Chapel Hill
February 2014

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