Impacts of HIV Treatment Regimens on Archived Drug Resistance
Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study
調査の概要
状態
詳細な説明
Aim/objectives: With the aim of determining the impact of antiretroviral regimen and switch on archived HIV-1 drug resistance mutation (DRM), the study's objectives are, to: (a) estimate the prevalence of DRM in virally suppressed HIV infection; (b) assess changes in archived resistance before and after switch; and (c) identify predictors of archived DRM after regimen switch.
Design: A prospective observational study
Setting: All HIV specialist clinic services in Hong Kong
Methods: Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression who are planned for regimen switch would be recruited. Controls are patients with and without low level viraemia (LLV) not planned for switch, matched by antiretroviral regimen. Blood samples would be collected before switch, shortly and then 2-3 years after switch. Nanopore sequencing would be performed to identify DRM present in HIV-1 proviral DNA. Transcription of relevant clinical record data would be made to contribute to statistical and phylogenetic analyses
Main outcome measures: Change in DRM frequency between baseline and followups at (a) short term and long term; (b) occurrence of virological failure and time to failure; (c) difference in DRM frequency between presence and absence of LLV, and switched and non-switched patients.
Anticipated outcome: The study results would determine if archived resistance clearance would change following ART switch, identify factors associated with persistence of archived resistance, and inform management on the application of proviral DNA testing in clinical practice.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Shui Shan Lee, MD
- 電話番号：+852 22528812
- メール：sslee@cuhk.edu.hk
研究連絡先のバックアップ
- 名前：Ngai Sze Wong, PhD
- 電話番号：+852 22528862
- メール：candy_wong@cuhk.edu.hk
研究場所
-
-
Hong Kong
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Hong Kong、Hong Kong、中国、0000
- 募集
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
-
コンタクト：
- Shui Shan Lee, MD
- 電話番号：+852 22528812
- メール：sslee@cuhk.edu.hk
-
コンタクト：
- Ngai Sze Wong, PhD
- 電話番号：+852 22528862
- メール：candy_wong@cuhk.edu.hk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients living with HIV who are (a) aged 18 or above, (b) on antiretroviral therapy, (c) has viral load <20 copies/mL at 2 time points for ≥6 months, (d) planning regimen switch.
- Patients for inclusion in the control group meet the same criteria (a) but they are not planned for switch. Controls include patients with low level viremia (LLV) as defined as ≥2 consecutive viral load level between 21 and 200 copies/mL in the preceding 2 years.
Exclusion Criteria:
- Patients living with HIV who (a) are pregnant, (b) have virologic failure, (c) are suffering from concurrent opportunistic infections, (d) are prisoners , (e) are unable to give consent, and (f) have mental illnesses.
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
コホートと介入
グループ/コホート |
|---|
|
Patients on ART planning for regimen switch
virally suppressed with viral undetectable at 2 consecutive timepoints prior to enrolment
|
|
Patients on ART not for regimen switch
with and without low level viraemia prior to enrolment
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportional difference of drug resistance mutation at short term after regimen switch
時間枠：from enrolment to 3-6 months
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Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and short term (3-6 months) after regimen switch
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from enrolment to 3-6 months
|
|
Proportional difference of drug resistance mutation at long term after regimen switch
時間枠：From enrolment to 2-3 years after regimen switch
|
Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and long term (2-3 years) after regimen switch
|
From enrolment to 2-3 years after regimen switch
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of drug resistance mutation
時間枠：at enrolment
|
Percentage of patients on antiretroviral therapy with drug resistance mutation (DRM) detected by proviral DNA testing at baseline
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at enrolment
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Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia
時間枠：at enrolment
|
Percentage difference in the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing between the presence and absence of low level viremia at baseline
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at enrolment
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prevalence of virologic failure
時間枠：From enrolment to 2-3 years
|
Prevalence of virologic failure in patients on antiretroviral therapy at 2-3 years after enrolment
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From enrolment to 2-3 years
|
協力者と研究者
捜査官
- 主任研究者：Shui Shan Lee, MD、S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始 (実際)
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
- HK HIV archived DRM
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
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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