deltatrials
Completed PHASE4 INTERVENTIONAL 4-arm NCT01448616

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

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

Sponsor: CONRAD

Updated 8 times since 2017 Last updated: Feb 14, 2023 Started: Feb 29, 2012 Primary completion: Jun 30, 2015 Completion: Jun 30, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Herpes Simplex Type II and is currently completed. CONRAD leads this study, which shows 8 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Mar 2023 · 15 months · monthly snapshotCompleted~Mar 2023 – ~Jul 2024 · 16 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. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE4

  4. Dec 2021 — Mar 2023 [monthly]

    Completed PHASE4

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE4

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Feb 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CONRAD
  • Gilead Sciences
  • University of Washington
Data source: University of Washington

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

Study Locations