Ulcers of Female Genital Organs
Conditions
Keywords
Pharmacokinetics, Herpes simplex virus, Genital herpes ulcers
Brief 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.
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.
Interventions
DRUGAcyclovir
Single dose of acyclovir 200mg was given for pk study
DRUGPlacebo
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the Curve (AUC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to re-epithelization and time to cessation of HSV shedding | 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. |
Countries
Zambia
Outcome results
None listed