Pharmacokinetic and GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Herpes
Intervention: acyclovir (Drug); matching placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Connie Celum, MD, MPH, Principal Investigator, Affiliation: University of Washington
Summary
1. PART 1: To measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg
orally in 60 African HIV-negative heterosexual women who have a history of GUD, are
HSV-2 seropositive, and HIV-1 seronegative.
2. PART 2: To 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 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.
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Pharmacokinetics Study
Primary outcome: To measure Area Under the Curve (AUC) from a single dose of acyclovir 400 mg orally in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease(GUD), are HSV-2 seropositive.
Secondary outcome: To examine the time to healing of genital lesions and duration of HSV shedding from GUD among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Exclusion Criteria:
- Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
- Prior hypersensitivity &/or allergic reaction to acyclovir
- Current use, or use within past 28 days, or an investigational agent
- Currently pregnant or nursing
- Currently plan to become pregnant during next 3 months
- Currently consume, on average, more than 7 drinks of alcohol per week (Part I)
- Current use of more than 20 cigarettes per day (Part I)
- Any condition that will interfere with successful completion of study procedures
Locations and Contacts
Reproductive Health and HIV Research Unit (RHRU), Johannesburg, South Africa; Recruiting
Sinead Delaney-Moretlwe, MD, DrPH, Email: sdelany@rhru.co.za
Sinead Delany-Moretlwe, MD, DrPH, Principal Investigator
Center for Infectious Disease Research of Zambia (CIDRZ), Lusaka, Zambia; Recruiting
Stewart Reid, MD, Email: stewart.reid@cidrz.org
Stewart Reid, MD, Principal Investigator
UCSF-University of Zimbabwe Collaboration, Harare, Zimbabwe; Completed
Additional Information
Starting date: January 2009
Ending date: December 2009
Last updated: June 26, 2009
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