健康な成人を対象とした長時間作用型カボテグラビル(CAB LA)からの切り替え後のカボテグラビル超長時間作用型(CAB ULA)の薬物動態、安全性、忍容性を評価する研究
健康な成人ボランティアを対象に長時間作用型カボテグラビルから超長時間作用型カボテグラビルに切り替えた場合の薬物動態、安全性、忍容性を評価する第1相単群反復投与試験
This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.
調査の概要
状態
状態
条件
条件
詳細な説明
The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Alabama
-
Mobile、Alabama、アメリカ、36608
- GSK Investigational Site
-
-
Florida
-
Doral、Florida、アメリカ、33172-2513
- GSK Investigational Site
-
-
Illinois
-
Oak Brook、Illinois、アメリカ、60532
- GSK Investigational Site
-
-
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
Inclusion Criteria:
- Adult participants greater than or equal to (>=) 18 years old, weighing at least 35 kg.
- Participants who are overtly healthy as determined by medical evaluation.
- Assigned male sex at birth or assigned female sex at birth. Participants assigned female sex at birth are eligible to participate if they are of non-childbearing potential, or if they are of childbearing potential and are not pregnant (confirmed by test), not breastfeeding, and are using a highly effective contraceptive method.
- Capable of giving written informed consent.
Healthcare staff will be eligible for inclusion in this study if:
- They are site employees responsible for administrative or clinical aspects of offering and administering CAB under the protocol at the site.
- Has the required qualifications according to their role and delegated the appropriate responsibilities by site Principal investigator (PI).
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
Exclusion Criteria:
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, neurological, or psychiatric disorders capable of significantly altering drug pharmacokinetics, interfering with the participant's ability to comply with the dosing schedule and/or protocol evaluations, or compromising participant safety.
- Current or anticipated need for chronic anti-coagulants.
- Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- History of ongoing or clinically relevant seizure disorder within the previous 2 years.
- Participants who pose a significant suicidality risk.
- History or presence of sensitivity to any of the study medications, study procedure-related medications, their components or drugs of their class, or an allergy that contraindicates participation.
- Participant has an implant/enhancement (including fillers) at the area of proposed injection; or tattoo or other dermatological condition overlying any area which may significantly interfere with interpretation of injection site reactions.
- Inflammatory skin conditions that compromise the safety of injections.
- Any acute laboratory abnormality that should preclude participation or exclusionary laboratory value.
- Human immunodeficiency virus (HIV-1 or HIV-2) infection.
- Reactive or positive HIV test.
- Signs and symptoms suggestive of acute HIV infection- that is not ruled out with non-reactive results using appropriate HIV tests.
- Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
- One or more exclusionary values for a screening ECG.
- Participants receiving any protocol-prohibited medication.
- Use of CAB LA for PrEP within 1 year.
- Concurrent participation in another clinical study in which an investigational product was received within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Positive pre-study drug/alcohol screen.
- History of or on-going high-risk behaviours that put the participant at increased risk for HIV infection.
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:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
実験的:CAB Group
Participants will receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23. |
CAB LA injection will be administered CAB ULA injection will be administered |
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 |
|---|---|
|
CAB LA 期終了時の CAB 血漿中濃度と CAB ULA 期終了時の CAB 血漿中濃度の比較
時間枠:23 か月目と 9 か月目との比較
|
23 か月目と 9 か月目との比較
|
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 |
|---|---|---|
|
CAB ULA注射後の各評価時点におけるCABの血漿濃度
時間枠:23ヶ月目まで
|
23ヶ月目まで
|
|
|
臨床検査値異常のある参加者の数
時間枠:32ヶ月目まで
|
32ヶ月目まで
|
|
|
時間の経過とともに検査パラメータが変化した参加者の数
時間枠:32ヶ月目まで
|
32ヶ月目まで
|
|
|
Number of participants with adverse events (AEs) (including Injection Site Reactions [ISRs]) as per severity
時間枠:Up to Month 32
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. |
Up to Month 32
|
|
Number of participants with ISRs by grade
時間枠:Up to Month 32
|
Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening |
Up to Month 32
|
|
Duration (Days) of ISRs by grade
時間枠:Up to Month 32
|
Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. |
Up to Month 32
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 223369
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?
IPD プランの説明
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
IPD 共有時間枠
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
IPD 共有アクセス基準
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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。