Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa (CogUK)
A Randomised, Prospective Study, Assessing Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa.
The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
The study will compare anti-HIV therapy combinations which are currently in use.
The patients will not have had any previous treatment for their HIV infection.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Impairment in neurocognitive(NC) function in HIV-infected subjects in the current anti-retroviraltreatment (cART) era has been associated with poor compliance with cART, reduced quality-of-life and increased mortality. Reported factors associated with the development of NC function impairment in HIV disease and risks associated with progression of such impairment include degree of immune suppression related to HIV infection, other chronic viral infections (such as chronic hepatitis C co-infection), age and central nervous system (CNS) antiretroviral drug exposure.
One modifiable factor which may be associated with the evolution of NC function impairment is the direct effect of cART on the central-nervous-system (CNS). Certain antiretroviral drugs such as zidovudine, lamivudine, abacavir, nevirapine, efavirenz and indinavir are known to achieve optimal exposure in the cerebro-spinal-fluid (CSF) whereas other drugs, such as the majority of the HIV-1 protease inhibitors penetrate less effectively. Studies to date suggest different cART regimens may have differing effects on NC performance. In the EuroSIDA study, the use of nucleoside-reverse-transcriptase inhibitors was found to specifically protect against the development of HIV related brain disease. More recently, in a small prospective study, ALTAIR, different effect on cerebral function was reported in subjects randomised to commence three different cART regimens.
The investigators propose, in a prospective, randomised study to assess the effects of two different antiretroviral regimens on NC function in HIV infected subjects commencing antiretroviral therapy for the first time.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Birmingham、イギリス
- Birmingham Heartlands Hospital:
-
Brighton、イギリス、BN1 9RE
- Brighton and Sussex University Hospital NHS Trust:
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London、イギリス
- St. Thomas' Hospital
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London、イギリス、SE5 9RJ
- Kings College Hospital
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London、イギリス、SW10 9NH
- Chelsea and Westminster Hospital NHS Trust
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London:、イギリス、W2 1NY
- St. Mary's Hospital
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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
Inclusion Criteria:
- HIV-1 infected males or females
- signed informed consent
- no previous antiretroviral treatment since HIV diagnosis
- screening CD4+ lymphocyte count <= 350 cells/ųL
- susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors) NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1 genotypic resistance report
- CCR5-tropic HIV based on genotypic resistance testing*
Exclusion Criteria:
• existing neurological disease
- hepatitis B or hepatitis C co-infection
- age under 18 years
- screening laboratory parameters > grade 2 (with the exception of cholesterol and triglycerides)
- current history of major depression or psychosis
- recent head injury (past three months)
- current alcohol abuse or drug dependence
- active opportunistic infection or significant co-morbidities
- patients who are receiving other concomitant medication which are not permitted, as listed in appendix 2
female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study
- are breast feeding
- are planning to become pregnant
- all participants unwilling to use a barrier method of contraception
- patients who in the opinion of the investigator are not candidates for inclusion in the study
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 |
|---|---|
|
アクティブコンパレータ：standard care
treatment with:
|
|
|
アクティブコンパレータ：Novel therapeutic approach
|
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive Function, Global Cognitive Score (Z-score)
時間枠：24 weeks, 48 weeks
|
When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. Score increase means improved performance of cognitive function |
24 weeks, 48 weeks
|
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 |
|---|---|---|
|
Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio
時間枠：48 weeks
|
The study team will assess the brain functions at each visit.
The results of the MRI scans will be compared, changes in N-acetyl aspartate/creatinine ratio over 48 weeks.
|
48 weeks
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Alan Winston、Imperial College London
出版物と役立つリンク
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 (実際)
一次修了
研究の完了 (実際)
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 (見積もり)
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
キーワード
その他の研究ID番号
その他の研究ID番号
- 1733
- 2011-002656-14 (EudraCT番号)
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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