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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Shui Shan Lee, MD
- 전화번호: +852 22528812
- 이메일: sslee@cuhk.edu.hk
연구 연락처 백업
- 이름: Ngai Sze Wong, PhD
- 전화번호: +852 22528862
- 이메일: candy_wong@cuhk.edu.hk
연구 장소
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Hong Kong
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Hong Kong, Hong Kong, 중국, 0000
- 모병
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
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연락하다:
- Shui Shan Lee, MD
- 전화번호: +852 22528812
- 이메일: sslee@cuhk.edu.hk
-
연락하다:
- Ngai Sze Wong, PhD
- 전화번호: +852 22528862
- 이메일: candy_wong@cuhk.edu.hk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Patients on ART planning for regimen switch
virally suppressed with viral undetectable at 2 consecutive timepoints prior to enrolment
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Patients on ART not for regimen switch
with and without low level viraemia prior to enrolment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportional difference of drug resistance mutation at short term after regimen switch
기간: 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
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Proportional difference of drug resistance mutation at long term after regimen switch
기간: From enrolment to 2-3 years after regimen switch
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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
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From enrolment to 2-3 years after regimen switch
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of drug resistance mutation
기간: at enrolment
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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
기간: at enrolment
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of virologic failure
기간: From enrolment to 2-3 years
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shui Shan Lee, MD, S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HK HIV archived DRM
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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