deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00362297

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults

Sponsor: University of Washington

Conditions Genital Herpes
Updated 8 times since 2017 Last updated: Nov 16, 2021 Started: Sep 30, 2006 Primary completion: Dec 31, 2008 Completion: Sep 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00362297, this PHASE4 trial focuses on Genital Herpes and remains completed. Sponsored by University of Washington, it has been updated 8 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Screening Assessment Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF): * Demographic Data: Date of birth, sex, marital status, education and race * Previous antiviral medication taken * History of sexually transmitted infections and sexual history. Start of Study Visit (Day 0) and Day 14, 28, 42, 56, 70, 84, 98 and 105 Follow-Up Visits. Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts. Crossover Study Visit Prior To Washout Period (Day 49-55) Participants will not be given study drug or placebo during the 7-day washout period. Daily Home Viral Sample Collection Participants will collect swabs from the genital mucosa four times per day...

Screening Assessment

Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):

* Demographic Data: Date of birth, sex, marital status, education and race * Previous antiviral medication taken * History of sexually transmitted infections and sexual history.

Start of Study Visit (Day 0) and Day 14, 28, 42, 56, 70, 84, 98 and 105 Follow-Up Visits.

Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts.

Crossover Study Visit Prior To Washout Period (Day 49-55)

Participants will not be given study drug or placebo during the 7-day washout period.

Daily Home Viral Sample Collection

Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.

Final Study Visit (Day 105)

At the final study visit at Day 105 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~May 2020 · 23 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE4

  5. May 2020 — Jan 2021 [monthly]

    Completed PHASE4

Show 3 earlier versions
  1. Jun 2018 — May 2020 [monthly]

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Sep 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Washington
Data source: University of Washington

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations