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Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcers of Female Genital Organs

Intervention: Acyclovir (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Stewart Reid, MD, Principal Investigator, Affiliation: Centre for Infectious Disease Research in Zambia


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Area under the Curve (AUC)

Secondary outcome: Time to re-epithelization and time to cessation of HSV shedding

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.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.


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


- 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.

Locations and Contacts

Centre for Infectious Disease Research in Zambia, Lusaka, Zambia
Additional Information

University of North Carolina website

Related publications:

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Starting date: January 2009
Last updated: December 11, 2014

Page last updated: August 23, 2015

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