Phase 4
N=73
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
Herpes Simplex Type II
Bottom Line
View on ClinicalTrials.gov: NCT01448616 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo — 22.9; 13.8; 21.3; 19.5 percentage of swabs positive (%) — p=0.086
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TDF (Drug); Placebo Vaginal Gel (Drug); Vaginal TFV Gel (Drug); Placebo Tablets (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo |
22.9; 13.8; 21.3; 19.5; 12.0; 20.4 | 0.086 |
| SECONDARY Within-person Changes in Log-copy Numbers of HSV |
4.02; 4.47; 3.71; 4.11; 4.40; 4.22 | 0.18 |
| SECONDARY Genital Lesion Rate |
11.8; 8.7; 13.6; 11.6; 7.1; 14.7 | 0.90 |
| SECONDARY Asymptomatic Shedding (Shedding on Days Without Genital Lesions) |
17.5; 7.6; 14.4; 13.7; 8.2; 12.1 | 0.010 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01448616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.