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OpenTrials
Completed

NCT Number: NCT00808405

GUD Clinical and Virologic Response to Acyclovir 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.

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Key information

Conditions

Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Health and HIV Research Unit (RHRU), Johannesburg, South Africa

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acyclovir

Drug

400mg taken orally three times daily for 5 days

Matching Placebo

Drug

matching placebo taken orally three times daily for 5 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)

Registry information

Official study title

Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Acronym: PK/GUD

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 15, 2008
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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