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
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
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Mar 2023 — Jul 2024 [monthly]
Completed PHASE4
-
Dec 2021 — Mar 2023 [monthly]
Completed PHASE4
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE4
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE4
-
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
- CONRAD
- Gilead Sciences
- University of Washington
For direct contact, visit the study record on ClinicalTrials.gov .