Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex Type II
Intervention: Tenofovir (Drug); placebo gel (Drug); tenofovir disoproxil fumarate (TDF) (Drug); placebo tablets (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Anna Wald, MD, MPH, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: HSV shedding
Secondary outcome: within-person changes in copy numbers of HSVAverage copy numbers of HSV Lesion rate Shedding on no lesion days Number of participants with adverse events (AEs) as a measure of safety and tolerability.
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 a run-in phase with twice daily swabbing. Following 4 weeks of
swabbing, participants will be randomized 2: 2:1 to one of three groups: 1) oral tenofovir
and placebo gel, 2) oral placebo and tenofovir gel, or 3) oral placebo and placebo gel.
Participants will begin treatment and swab the genital region twice daily for 5 more weeks.
Study drug will be administered daily.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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.
Locations and Contacts
University of Washington Virology Research Clinic, Seattle, Washington 98104, United States
Additional Information
Starting date: February 2012
Last updated: June 3, 2014
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