Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

September 13, 2017 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Acyclovir
Single dose of acyclovir 200mg was given for pk study
Active Comparator: Acyclovir
400 mg Acyclovir three times daily for 5 days
Drug: Acyclovir
Single dose of acyclovir 200mg was given for pk study
Placebo Comparator: Placebo
Placebo three times daily for 5 days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the Curve (AUC)
Time Frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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.
0, 2, 3, 4, 6 and 8 hours post acyclovir administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to re-epithelization and time to cessation of HSV shedding
Time Frame: days 1-5, 7, 9, 11 and 13
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.
days 1-5, 7, 9, 11 and 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Stewart Reid, MD, Centre for Infectious Disease Research in Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDRZ 1208/IRB12-0390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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