Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.
The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究連絡先
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
研究場所
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Florida
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Ft. Pierce、Florida、アメリカ、34982
- 募集
- Midway Immunology and Research Center
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Texas
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Houston、Texas、アメリカ、77098
- 募集
- The Crofoot Research Center, INC
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参加基準
適格基準
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, 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 agree to use approved method(s) of contraception.
- Negative serum pregnancy test at screening and negative urine test at enrollment.
- Receiving B/F/TAF for ≥ 6 months prior to screening.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months before and at screening.
- No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports.
- CD4 ≥ 200 cells/mm^3 at screening
Key Exclusion Criteria:
- Plans to breastfeed during the study period and 60 days following the last dose of study intervention.
- History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.
- Creatinine clearance according to the Cockcroft-Gault formula < 60 mL/min.
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：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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アクティブコンパレータ：Treatment Arm A: B/F/TAF
Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally
他の名前：
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実験的：Treatment Arm B: GS-3242 + LEN
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment C), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally Tablet administered orally
他の名前：
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実験的：Treatment Arm C: GS-3242 + LEN
Participants will be randomized to oral loading dose of GS-3242 in combination with LEN, followed by a once-weekly oral combination regimen of GS-3242 and LEN (at a different dose than Treatment Arm B), administered concomitantly for at least 48 weeks. After Week 48, participants in the Randomized Phase may be offered to continue to receive study drug in the Extension Phase. |
Tablet administered orally Tablet administered orally
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
時間枠：Week 24
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Week 24
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 12
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Week 12
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Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 48
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Week 48
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 12
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Week 12
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 24
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Week 24
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Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
時間枠：Week 48
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Week 48
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Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
時間枠：Week 12
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Week 12
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Change From Baseline in CD4 Cell Count at Week 24
時間枠：Week 24
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Week 24
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Change From Baseline in CD4 Cell Count at Week 48
時間枠：Week 48
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Week 48
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12
時間枠：Week 12
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Week 12
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24
時間枠：Week 24
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Week 24
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The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48
時間枠：Week 48
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Week 48
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Pharmacokinetic (PK) Parameter: Cmax of GS-3242
時間枠：Up to 48 weeks
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Cmax is defined as the maximum observed concentration of drug. |
Up to 48 weeks
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PK Parameter: Tmax of GS-3242
時間枠：Up to 48 weeks
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Tmax is defined as the time (observed time point) of Cmax. |
Up to 48 weeks
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PK Parameter: Ctau of GS-3242
時間枠：Up to 48 weeks
|
Ctau is defined as the observed drug concentration at the end of the dosing interval. |
Up to 48 weeks
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PK Parameter: AUCtau of GS-3242
時間枠：Up to 48 weeks
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AUCtau is defined as the area under the concentration versus time curve over the dosing interval. |
Up to 48 weeks
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協力者と研究者
捜査官
捜査官
- スタディディレクター：Gilead Study Director、Gilead Sciences
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- GS-US-782-8079-01
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
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