Status:
COMPLETED
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
Lead Sponsor:
University of Washington
Collaborating Sponsors:
CONRAD
Gilead Sciences
Conditions:
Herpes Simplex Type II
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shed...
Detailed Description
The investigators propose a randomized, double-blind, placebo-controlled, cross-over study of 55 adult, healthy women who are HSV-2 seropositive and HIV-1 seronegative. Women will first participate in...
Eligibility Criteria
Inclusion
- Women age 18-50
- HSV-2 seropositive by the University of Washington (UW) Western blot
- History of recurrent genital herpes, with more than 4 recurrences but less than 10 in the last year or, if currently on suppressive therapy, with more than 4 recurrences but less than 10 in the year prior to starting suppressive therapy
- HIV negative
- General good health
- Willing to not use antiviral therapy (other than the study drug) for the duration of the study
- Willing to obtain a swab from genital secretions twice daily for the duration of the study
- Willing to use effective birth control
- Able to provide written informed consent at screening and enrollment
Exclusion
- HIV positive or at high risk for HIV acquisition (intravenous drug user or HIV+ sex partner)
- Hepatitis B (HepB) antigen (Ag) positive, or at high risk for HepB acquisition and not vaccinated
- Have a history of adverse reaction to tenofovir and/or adefovir
- Immunosuppressive medications, except for intranasal or topical (not high potency) steroids.
- Any kidney disease, or renal insufficiency, defined as serum creatinine \>1.5 mg/dl. Participants with a prior history of a single episode of pyelonephritis will be eligible.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times upper limit of normal
- Pregnancy, as confirmed by a urine pregnancy test, planning to become pregnant during the course of the trial, or breast-feeding.
- Serious medical conditions or active infections
- Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01448616
Start Date
February 1 2012
End Date
June 1 2015
Last Update
February 16 2023
Active Locations (1)
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1
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104