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

Primary Purpose

Genital Herpes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
acyclovir
matching placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring herpes simplex virus, acyclovir, HSV shedding, women, Africa

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Reproductive Health and HIV Research Unit (RHRU)
  • Center for Infectious Disease Research of Zambia (CIDRZ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

acyclovir

placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to Healing of Genital Lesions
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
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

Full Information

First Posted
November 25, 2008
Last Updated
November 15, 2013
Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00808405
Brief Title
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Acronym
PK/GUD
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
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
herpes simplex virus, acyclovir, HSV shedding, women, Africa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acyclovir
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
acyclovir
Intervention Description
400mg taken orally three times daily for 5 days
Intervention Type
Drug
Intervention Name(s)
matching placebo
Intervention Description
matching placebo taken orally three times daily for 5 days.
Primary Outcome Measure Information:
Title
Time to Healing of Genital Lesions
Description
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
Time Frame
Days 1-5, 7, 9, 11, 13
Secondary Outcome Measure Information:
Title
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR
Description
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
Time Frame
Days 1-5, 7, 9, 11, 13

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Celum, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Wald, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Health and HIV Research Unit (RHRU)
City
Johannesburg
Country
South Africa
Facility Name
Center for Infectious Disease Research of Zambia (CIDRZ)
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
18572080
Citation
Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.
Results Reference
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PubMed Identifier
22330926
Citation
Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations. Antimicrob Agents Chemother. 2012 May;56(5):2777-9. doi: 10.1128/AAC.06160-11. Epub 2012 Feb 13.
Results Reference
background
PubMed Identifier
22183840
Citation
Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey L, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-controlled trial. Sex Transm Dis. 2012 Jan;39(1):21-4. doi: 10.1097/OLQ.0b013e31823b50c6.
Results Reference
derived

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GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

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