Pharmacokinetic and GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received: November 25, 2008 Last Updated: January 13, 2010 History of Changes

Sponsor:	University of Washington
Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00808405

Purpose

PART 1: To measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg orally in 60 African HIV-negative heterosexual women who have a history of GUD, are HSV-2 seropositive, and HIV-1 seronegative.
PART 2: To 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 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.

Condition	Intervention
Genital Herpes	Drug: acyclovir Drug: matching placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

To measure Area Under the Curve (AUC) from a single dose of acyclovir 400 mg orally in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease(GUD), are HSV-2 seropositive. [ Time Frame: 0, 1,2, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the time to healing of genital lesions and duration of HSV shedding from GUD 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: Healing and shedding assessed days 1-5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
acyclovir: Active Comparator	Drug: acyclovir For Part II of the study, subjects will receive 400mg orally three times daily for 5 days
placebo: Placebo Comparator	Drug: matching placebo For Part II of the study, subjects will receive matching placebo to take orally three times daily for 5 days.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Exclusion Criteria:

Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
Prior hypersensitivity &/or allergic reaction to acyclovir
Current use, or use within past 28 days, or an investigational agent
Currently pregnant or nursing
Currently plan to become pregnant during next 3 months
Currently consume, on average, more than 7 drinks of alcohol per week (Part I)
Current use of more than 20 cigarettes per day (Part I)
Any condition that will interfere with successful completion of study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808405

Locations

South Africa
Reproductive Health and HIV Research Unit (RHRU)
Johannesburg, South Africa
Zambia
Center for Infectious Disease Research of Zambia (CIDRZ)
Lusaka, Zambia
Zimbabwe
UCSF-University of Zimbabwe Collaboration
Harare, Zimbabwe

Sponsors and Collaborators

University of Washington

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Connie Celum, MD, MPH

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Connie Celum MD, MPH/ Principal Investigator, Protocol Co-Chair )
Study ID Numbers:	34708-A, UO1 AI 52054
Study First Received:	November 25, 2008
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00808405 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Herpes Simplex
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Genital Diseases, Male
Antiviral Agents
Pharmacologic Actions

Herpesviridae Infections
Virus Diseases
Genital Diseases, Female
Acyclovir
Therapeutic Uses
Sexually Transmitted Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on February 08, 2010