Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding (NCT01448616) | Clinical Trial Compass
CompletedPhase 4
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
United States73 participantsStarted 2012-02
Plain-language 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) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 condi…
What they're measuring
1
HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase