Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Acyclovir

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.