Herpes Simplex Type IIPhase 4NCT01448616

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

A Phase 4 study testing TDF and Vaginal TFV Gel in people with Herpes Simplex Type II, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Herpes Simplex Type II
What is being tested?: TDF and Vaginal TFV Gel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Jun 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

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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

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington Virology Research Clinic
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Read the 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.

Conditions: Herpes Simplex Type II
Being tested: TDF, Placebo Vaginal Gel, Vaginal TFV Gel, Placebo Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDFDrug
Also called Tenofovir disoproxil fumarate (TDF) oral tablets
Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
Placebo Vaginal GelDrug
Also called Placebo gel
Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints.
Vaginal TFV GelDrug
Also called Tenofovir 1% Vaginal Gel
Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
Placebo TabletsDrug
Also called Oral placebo
TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.

Study groups in NCT01448616
Study group	Role	What they receive
Run-in Phase	No intervention	Women will first participate in a run-in phase with twice daily swabbing.
Study Drug Phase: TDF	Experimental	Participants will take tenofovir disoproxil fumarate (TDF) tablets and apply a placebo vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily. Receives: Drug: TDF; Drug: Placebo Vaginal Gel
Study Drug Phase: Vaginal TFV Gel	Experimental	Participants will take oral placebo tablets and apply a tenofovir 1% (TFV) vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily. Receives: Drug: Vaginal TFV Gel; Drug: Placebo Tablets
Study Drug Phase: Double Placebo	Placebo comparator	Participants will take oral placebo tablets and apply a placebo vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily. Receives: Drug: Placebo Vaginal Gel; Drug: Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo
The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.
Measured: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

Secondary outcomes (3)

Within-person Changes in Log-copy Numbers of HSV
The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment.
Measured: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Genital Lesion Rate
The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment.
Measured: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Asymptomatic Shedding (Shedding on Days Without Genital Lesions)
Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.
We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment.
Measured: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2015

First posted7 Oct 2011 (estimated)
Study startFeb 2012
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Herpes Simplex Type IIStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01448616
Sponsor's protocol ID: 41250
Status last verified: Feb 2023
First submitted: 14 Sep 2011
Last updated: 16 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Johnston C, Harrington R, Jain R, Schiffer J, Kiem HP, Woolfrey A. Safety and Efficacy of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Adults Undergoing Autologous or Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies. Biol Blood Marrow Transplant. 2016 Jan;22(1):149-56. doi: 10.1016/j.bbmt.2015.08.006. Epub 2015 Aug 8.
PubMed 26265463
Bender Ignacio RA, Perti T, Magaret AS, Rajagopal S, Stevens CE, Huang ML, Selke S, Johnston C, Marrazzo J, Wald A. Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-over Trial. J Infect Dis. 2015 Dec 15;212(12):1949-56. doi: 10.1093/infdis/jiv317. Epub 2015 Jun 4.
PubMed 26044291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Herpes Simplex Type II trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial
ClinicalTrials.gov ID: NCT01448616
Acronym / sponsor ID: 41250
Conditions: Herpes Simplex Type II
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: CONRAD, Gilead Sciences
Study start: Feb 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 7 Oct 2011 (estimated)
Results: Posted 12 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Run-in Phase	No intervention	–Women will first participate in a run-in phase with twice daily swabbing.
Study Drug Phase: TDF	Experimental	Drug: TDF, Drug: Placebo Vaginal GelParticipants will take tenofovir disoproxil fumarate (TDF) tablets and apply a placebo vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily.
Study Drug Phase: Vaginal TFV Gel	Experimental	Drug: Vaginal TFV Gel, Drug: Placebo TabletsParticipants will take oral placebo tablets and apply a tenofovir 1% (TFV) vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily.
Study Drug Phase: Double Placebo	Placebo comparator	Drug: Placebo Vaginal Gel, Drug: Placebo TabletsParticipants will take oral placebo tablets and apply a placebo vaginal gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drugs will be administered once daily.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TDFAlso: Tenofovir disoproxil fumarate (TDF) oral tabletsOral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.	Drug	Study Drug Phase: TDF
Placebo Vaginal GelAlso: Placebo gelStudy participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible. The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints.	Drug	Study Drug Phase: Double Placebo, Study Drug Phase: TDF
Vaginal TFV GelAlso: Tenofovir 1% Vaginal GelTenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.	Drug	Study Drug Phase: Vaginal TFV Gel
Placebo TabletsAlso: Oral placeboTDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.	Drug	Study Drug Phase: Double Placebo, Study Drug Phase: Vaginal TFV Gel

Primary outcome

HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo
Time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.

3 secondary outcomes

Within-person Changes in Log-copy Numbers of HSV
Time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Genital Lesion Rate
Time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Asymptomatic Shedding (Shedding on Days Without Genital Lesions)
Time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase

Results and safety

Results posted to the registry on 12 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Group	73	64
Oral TDF + Vaginal Placebo Gel	0	0
Oral Placebo + Vaginal Tenofovir 1% Gel	0	0
Placebo Oral + Placebo Vaginal Gel	0	0

Primary outcome: HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo

Time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase. Number (95% Confidence Interval). Unit: percentage of swabs positive (%)

Measure	Oral TDF + Vaginal Placebo Gel n = 24	Oral Placebo + Vaginal TFV Gel n = 27	Oral Placebo + Vaginal Placebo n = 13
Lead-in Phase	22.9 (20.6 to 25.2)	13.8 (12.1 to 15.7)	21.3 (18.4 to 24.5)
Treatment Phase	19.5 (17.4 to 21.8)	12.0 (10.3 to 13.9)	20.4 (17.0 to 24.1)

Oral TDF + Vaginal Placebo Gel: Risk Ratio (RR): 0.86 (95% CI 0.71 to 1.01), p = 0.086, Poisson GLME
Oral Placebo + Vaginal TFV Gel: Risk Ratio (RR): 0.94 (95% CI 0.75 to 1.16), p = 0.54, Poisson GLME
Oral Placebo + Vaginal Placebo: Risk Ratio (RR): 0.90 (95% CI 0.67 to 1.22), p = 0.47, Poisson GLME

Population analysed: This is the intent-to-treat population (all randomized participants returning at least 1 swab in each phase of study)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected during the course of the lead-in phase (4 weeks) and the treatment (study drug) phase (5 weeks) and final AEs were recorded at a post-treatment follow up telephone visit 2 weeks after completing the study products.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Group	0 of 73 (0%)	11 of 73 (15.1%)	Not reported
Oral TDF + Vaginal Placebo Gel	0 of 24 (0%)	12 of 24 (50%)	Not reported
Oral Placebo + Vaginal Tenofovir 1% Gel	0 of 27 (0%)	11 of 27 (40.7%)	Not reported
Placebo Oral + Placebo Vaginal Gel	0 of 13 (0%)	3 of 13 (23.1%)	Not reported

Limitations and caveats (from the sponsor): The study was not powered to detect differences in lesion rate; the study was appropriately powered to detect a 50% decrease in viral shedding only, and therefore may have been underpowered to detect significant findings for secondary outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26265463Johnston C, Harrington R, Jain R, Schiffer J, Kiem HP, Woolfrey A. Safety and Efficacy of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Adults Undergoing Autologous or Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies. Biol Blood Marrow Transplant. 2016 Jan;22(1):149-56. doi: 10.1016/j.bbmt.2015.08.006. Epub 2015 Aug 8.
Derived from this study: PubMed 26044291Bender Ignacio RA, Perti T, Magaret AS, Rajagopal S, Stevens CE, Huang ML, Selke S, Johnston C, Marrazzo J, Wald A. Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-over Trial. J Infect Dis. 2015 Dec 15;212(12):1949-56. doi: 10.1093/infdis/jiv317. Epub 2015 Jun 4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Wald, MD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TDF and Vaginal TFV Gel in people with Herpes Simplex Type II, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo (time frame: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01448616, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.