Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: CONRAD; Gilead Sciences
• Treatments: Tenofovir

Criteria

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 conditions or active infections

• Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.