N/A
N=88
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Genital Herpes
Bottom Line
View on ClinicalTrials.gov: NCT00808405 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Time to Healing of Genital Lesions — 5.1; 6.0 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acyclovir (Drug); matching placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Healing of Genital Lesions |
5.1; 6.0 | — |
| SECONDARY Time to First Negative Herpes Simplex Virus (HSV) DNA PCR |
3.0; 5.0 | — |
Summary
To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (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.
Eligibility 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 of age
Exclusion Criteria
- Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
- Prior hypersensitivity &/or allergic reaction to acyclovir
- Use of probenicid
- Current use, or use within past 28 days, of an investigational agent
- Currently pregnant or nursing
- Currently plan to become pregnant during next 3 months
- Any condition that will interfere with successful completion of study procedures
Data sourced from ClinicalTrials.gov (NCT00808405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.