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Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

Primary Purpose

Ulcers of Female Genital Organs

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Acyclovir
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcers of Female Genital Organs focused on measuring Pharmacokinetics, Herpes simplex virus, Genital herpes ulcers

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Infectious Disease Research in Zambia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Part 1 PK

Acyclovir

Placebo

Arm Description

400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.

400 mg Acyclovir three times daily for 5 days

Placebo three times daily for 5 days

Outcomes

Primary Outcome Measures

Area under the Curve (AUC)
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.

Secondary Outcome Measures

Time to re-epithelization and time to cessation of HSV shedding
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.

Full Information

First Posted
January 31, 2014
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02053142
Brief Title
Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
Official Title
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers of Female Genital Organs
Keywords
Pharmacokinetics, Herpes simplex virus, Genital herpes ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 PK
Arm Type
Experimental
Arm Description
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
Arm Title
Acyclovir
Arm Type
Active Comparator
Arm Description
400 mg Acyclovir three times daily for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo three times daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Intervention Description
Single dose of acyclovir 200mg was given for pk study
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Area under the Curve (AUC)
Description
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.
Time Frame
0, 2, 3, 4, 6 and 8 hours post acyclovir administration
Secondary Outcome Measure Information:
Title
Time to re-epithelization and time to cessation of HSV shedding
Description
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.
Time Frame
days 1-5, 7, 9, 11 and 13

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Reid, MD
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Infectious Disease Research in Zambia
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

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Links:
URL
http://www.unc.edu
Description
University of North Carolina website

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Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

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