Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
A Phase 2b, Randomized, Double-Blind, Active-Control, Parallel-Group Study to Evaluate the Safety and Efficacy of GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
The goal of this clinical study is to compare the study drug GS-1179, versus valacyclovir (VACV) in herpes simplex virus type 2 (HSV-2) seropositive participants with recurrent genital herpes.
The primary objective of this study are to evaluate the safety and tolerability of GS-1179 versus VACV and to evaluate the antiviral effect of GS-1179 versus VACV.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Gilead Clinical Study Information Center
- 電話番号：1-833-445-3230 (GILEAD-0)
- メール：GileadClinicalTrials@gilead.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
- Individuals assigned male or female at birth, 18 years of age or older at screening, able to understand and give written informed consent and comply with treatment and follow up. Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must be nonpregnant, nonlactating, and agree to use protocol-specified method(s) of contraception.
- Individual is HSV-2 seropositive (or HSV-1 seropositive AND HSV-2 seropositive)
- Individual has a history of recurrent genital herpes for at least 1 year, with 4 to 9 clinical occurrences in the last year or, if currently on suppressive therapy, 4 to 9 occurrences a year prior to initiating suppressive therapy.
- Other than HSV infection, individual is in good health (as determined by the investigator). Medical history and physical examination should be without clinically significant abnormalities.
Key Exclusion Criteria:
- Individual has an acute episode of genital herpes during screening or on Day 1 prior to dosing.
- Individual has any other clinically significant medical, behavioral, mental condition, substance use disorder, or pharmacologic or surgical treatment that, in the opinion of the investigator or the sponsor, may interfere with efficacy or safety assessments, or the absorption, distribution, and/or elimination of the study drug, or make the individual unsuitable for study participation.
- Individual has a history of refractory or resistant HSV infection to any HSV-specific nucleoside analog including valacyclovir, acyclovir, famciclovir, penciclovir, ganciclovir, or valganciclovir.
- Individual has had treatment with any investigational or approved helicase-primase inhibitor (HPI) (including ABI-5366, ABI-1179, pritelivir, adibelivir [IM-250], amenamavir) or received an investigational HSV vaccine. However, individuals may be eligible if they participated in an investigational HPI study or an investigational HSV vaccine study but have sponsor documentation that they did not receive active product (eg, placebo recipients).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：GS-1179 High Dose + VACV Placebo to Match (PTM)
Participants will be randomized to receive a high-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. |
Administered orally Administered orally |
|
実験的：GS-1179 Low Dose + VACV Placebo to Match (PTM)
Participants will be randomized to receive a low-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days. |
Administered orally Administered orally |
|
アクティブコンパレータ：VACV + GS-1179 PTM
Participants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days. |
Administered orally Administered orally |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
時間枠：Enrollment up to 92 days
|
Enrollment up to 92 days
|
|
Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
時間枠：Enrollment up to 92 days
|
Enrollment up to 92 days
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
時間枠：First dose date up to 92 days
|
First dose date up to 92 days
|
|
Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants Free of Genital Herpes Recurrences at Day 92
時間枠：Day 92
|
Day 92
|
|
|
Proportion of Participants Free of Genital Herpes Recurrences at Day 120
時間枠：Day 120
|
Day 120
|
|
|
Genital Herpes Lesion Rate During the Treatment Period
時間枠：Up to 92 days
|
Up to 92 days
|
|
|
Genital Herpes Lesion Duration During the Treatment Period
時間枠：Up to 92 days
|
Up to 92 days
|
|
|
Virologically Confirmed Genital Herpes Lesion Rate During the Treatment Period
時間枠：Up to 92 days
|
Up to 92 days
|
|
|
Virologically Confirmed Genital Herpes Lesion Duration During the Treatment Period
時間枠：Up to 92 days
|
Up to 92 days
|
|
|
Time to Suppression of HSV-2 Shedding
時間枠：Up to 92 days
|
Up to 92 days
|
|
|
Number of HSV-2 Shedding Episodes During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Duration of HSV-2 Shedding Episodes During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Proportion of Participants With Subclinical HSV-2 Shedding During the Swabbing Period
時間枠：Day 8 to Day 38
|
Subclinical HSV-2 shedding is defined as swabs testing positive for HSV-2 DNA during the Swabbing Period that are not accompanied by lesions. |
Day 8 to Day 38
|
|
HSV-2 DNA (Copies/mL) for Swab Samples that are Positive for HSV-2 DNA During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
HSV-2 DNA (Copies/mL) for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Proportion of Swab Samples With HSV-2 DNA > 4 log10 Copies/mL for Positive Swab Samples in the Absence of Lesions (Subclinical Shedding) During the Swabbing Period
時間枠：Day 8 to Day 38
|
Day 8 to Day 38
|
|
|
Plasma Pharmacokinetic (PK) Parameters: Cmax of GS-1179
時間枠：Day 1 up to 92 days
|
Cmax is defined as the maximum observed concentration of drug at steady state. |
Day 1 up to 92 days
|
|
Plasma PK Parameters: AUCtau of GS-1179
時間枠：Day 1 up to 92 days
|
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state. |
Day 1 up to 92 days
|
|
Plasma PK Parameters: Ctrough of GS-1179
時間枠：Day 1 up to 92 days
|
Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state. |
Day 1 up to 92 days
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Gilead Study Director、Gilead Sciences
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GS-US-578-8029
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。