Trial record 6 of 8 for:    NIAID | herpes genitalis

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
  Purpose

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.


Condition Intervention
Ulcers of Female Genital Organs
Drug: Acyclovir
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053142

Locations
Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Stewart Reid, MD Centre for Infectious Disease Research in Zambia
  More Information

Additional Information:
Publications:

Responsible Party: Stewart Reid, MD, Research Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02053142     History of Changes
Other Study ID Numbers: 12-0390
Study First Received: January 31, 2014
Last Updated: February 6, 2014
Health Authority: Zambia: Research Ethics Committee
Zambia: Ministry of Health
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Pharmacokinetics
Herpes simplex virus
Genital herpes ulcers

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Ulcer
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014