TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
2012年12月10日 更新者：Tibotec Pharmaceuticals, Ireland
A Study to Survey the Swallowability of Uncoated 200-mg Tablets of Etravirine in HIV-1 Infected Subjects
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients.
In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made.
The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
調査の概要
詳細な説明
This trial is designed to elicit the swallowability of two formulations of 200 mg tablets of etravirine (ETR).
The trial will allow the assessment of the swallowability of the 200 mg uncoated tablet, the 200 mg film-coated tablet and make comparisons between these tablets and with the current commercially available 100 mg (uncoated) tablets.
The trial will be performed in HIV-1 infected patients who are currently taking etravirine (ETR) at a total daily dose of 400 mg (four 100 mg tablets, as whole tablets orally) as part of an antiretroviral regimen with virologic suppression (< 50 copies/mL for at least three months).
The trial includes only patients who are already taking etravirine since these patients will have pill taking experience and will also have experience with the commercially available 100 mg tablet formulation.
A minimum of 45 patients will be included in the trial to assure a sample representative of the HIV-1 infected population.
Patients will be given a single dose of the etravirine (ETR) uncoated 200 mg tablet in the morning, and then complete a questionnaire related to that intake.
Within 30 minutes, they will be administered the coated 200 mg formulation, followed by a questionnaire.
Assessments of the 200 mg tablets will be made in a single-blinded fashion.
As the patient will be administered two 200mg tablets in the morning, he/she does not need to take an evening dose on the day of these assessments.
The questionnaire will be used to assess swallowability of the 200 mg formulations and of their current 100 mg tablets, and will also evaluate patient preferences.
Patients will be followed up for safety and tolerability for one week due to the short duration the patient will be on study treatment; it will be difficult to distinguish between Adverse Events (AEs) resulting from their current etravirine (ETR) intake (four 100 mg tablets) versus the study intake (two 200 mg tablets).
A single dose of an etravirine uncoated 200 mg tablet in the morning, followed by completion of a questionnaire related to that intake.
Within 30 minutes, patients will be administered the coated 200 mg formulation, again followed by a questionnaire.
Maximum 2 weeks screening, 1 day treatment, 1 week follow up.
Total duration of participation is 2 weeks maximum.
研究の種類
介入
入学 (実際)
49
段階
- フェーズ 1
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)
- All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits
- Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Patient can comply with the protocol requirements
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial
- Pregnant or breastfeeding female patient
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：001
etravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
|
One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
|
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 |
|---|---|
|
Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet
時間枠：Assessment visit (Day 1)
|
Assessment visit (Day 1)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年3月1日
一次修了 (実際)
2010年5月1日
研究の完了 (実際)
2010年5月1日
試験登録日
最初に提出
2010年3月11日
QC基準を満たした最初の提出物
2010年3月18日
最初の投稿 (見積もり)
2010年3月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月11日
QC基準を満たした最後の更新が送信されました
2012年12月10日
最終確認日
2012年12月1日
詳しくは
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