Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial
| City: |
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Seattle |
| State: |
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Washington |
| Zip Code: |
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98104 |
| Conditions: |
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Herpes Simplex Type II |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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 conditions or active infections
- Any other conditions that in the judgment of the investigator would preclude
successful completion of the clinical trial.
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| NCT ID: |
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NCT01448616 |
| Primary Contact: |
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Principal Investigator
Anna Wald, MD, MPH
University of Washington
Virology Research Clinic
Phone: (206) 520-4340
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| Backup Contact: |
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N/A |
| Location Contact: |
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Seattle, Washington 98104
United States
Virology Research Clinic
Phone: 206-520-4340
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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