Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study
연구 개요
상태
정황
상세 설명
DESIGN HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24
All subjects will undergo routine monitoring including plasma HIV-1 RNA, CD4/CD8 count, hematology, chemistry and fasting lipids. Resistance testing will be done in all patients who experience virologic failure. Single-copy HIV-1 assay will be done to quantify residual viremia.
DURATION 48 weeks
SAMPLE SIZE 90 subjects
POPULATION HIV-1-infected men and women, 18 years and older, with CD4 nadir > 200 cells/mm3, no baseline resistance, no history of virologic failure, and HIV RNA <50 copies/mL for at least 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug regimen
REGIMEN Subjects will be randomized (1:1) to:
Arm 1: dolutegravir 50 mg plus lamivudine 300 mg once daily OR Arm 2: Continue current DHHS recommended or alternative three-drug antiretroviral regimen
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국
- University of California San Diego
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Georgia
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Atlanta, Georgia, 미국
- Emory University
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, 미국
- Brigham and Women's Hospital
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New York
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New York, New York, 미국
- Cornell University
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Ohio
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Cincinnati, Ohio, 미국
- University of Cincinnati
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Columbus, Ohio, 미국
- The Ohio State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- HIV-1 Infection
- HIV-1 RNA <50 copies/mL on all measurements within 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug antiretroviral regimen. (A history of switching for simplification and/or tolerability is allowed. At least two measurements within the previous 48 weeks are required prior to study screening.)
- No history of virologic failure, defined as consecutive HIV RNA > 50 copies/mL after 12 months of initiating ART. An isolated (non-consecutive) HIV RNA > 50 copies/mL (but less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the 48-week window prior to study entry.
- Screening plasma HIV RNA < 20 copies/mL using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test V2.0, obtained within 45 days prior to study entry
- Nadir CD4 count >200 cells/mm
- Pretreatment genotype documenting no mutations in the protease or reverse transcriptase genes
- No known resistance to integrase inhibitors
- Laboratory values obtained within 45 days prior to study entry:
ANC >750 Hemoglobin >10 g/dL Platelets >50,000 Calculated creatinine clearance (CrCl) >50 mL/min
- Negative serum or urine pregnancy test
- Men and women age greater or equal to 18 years.
- Ability to continue current regimen (i.e, have uninterrupted access)
- No evidence of chronic hepatitis B
Exclusion Criteria:
- Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- Treatment within 30 days prior to study entry with immune modulators
- Vaccination within 7 days
- Active HCV treatment or anticipated need for treatment within study period. (HCV infection alone is not exclusionary)
- Unstable liver disease or severe hepatic impairment
- Known allergy or hypersensitivity to DTG or lamivudine.
- Active drug or alcohol use or dependence that could interfere with adherence to study requirements
- ALT (alanine aminotransferase) >5 x ULN (upper limit of normal) OR ALT >3 x ULN and total bilirubin >1.5 x ULN (with 35% direct bilirubin)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: dolutegravir plus lamivudine
dolutegravir 50 mg plus lamivudine 300 mg once daily
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50 mg tablet by mouth once daily for 48 weeks
다른 이름들:
300 mg tablet by mouth once daily for 48 weeks
다른 이름들:
|
|
활성 비교기: Continue current ART regimen
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
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Continue current DHHS recommended or alternative three-drug antiretroviral regimen
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants With Treatment Failure
기간: 24 weeks
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Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
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24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants With Virologic Success
기간: 48 weeks
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Proportion of participants with virologic success (<50 copies/mL) based on FDA snapshot definition
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48 weeks
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Change in CD4 Count From Baseline to Week 48
기간: Baseline and 48 weeks
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Change in CD4 count between arms will be presented in the attached statistical analysis table
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Baseline and 48 weeks
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Change in Total Cholesterol From Baseline to Week 48
기간: Baseline and 48 weeks
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Change in Total Cholesterol between arms will be presented in the attached statistical analysis table
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Baseline and 48 weeks
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Change in LDL Cholesterol From Baseline to Week 48
기간: Baseline and Week 48
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Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table
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Baseline and Week 48
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Change in Creatinine Clearance From Baseline to Week 48
기간: Baseline and Week 48
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Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table
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Baseline and Week 48
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Drug Resistance Associated Mutations
기간: 48 weeks
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Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure
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48 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Residual Viremia by HIV-1 Single-copy Assay
기간: 48 weeks
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Difference in HIV-1 detection by the HIV-1 single copy assay between arms will be presented in statistical analysis
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48 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- ASPIRE
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