Ulcers of Female Genital Organs Clinical Trial
Official title:
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
| Verified date | December 2014 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Zambia | Centre for Infectious Disease Research in Zambia | Lusaka |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | National Institute of Allergy and Infectious Diseases (NIAID) |
Zambia,
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* Note: There are 38 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the Curve (AUC) | 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. | 0, 2, 3, 4, 6 and 8 hours post acyclovir administration | |
| Secondary | Time to re-epithelization and time to cessation of HSV shedding | 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. | days 1-5, 7, 9, 11 and 13 |