HIV-1 소아 및 청소년을 대상으로 빅테그라비르/레나카파비르에 대한 연구
HIV-1 감염 아동 및 청소년을 대상으로 빅테그라비르/레나카파비르의 약동학, 안전성 및 항바이러스 활성을 평가하기 위한 2/3상 공개 라벨 연구
The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN.
The primary objectives of this study are:
- To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1.
- To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Cape Town, 남아프리카, 7505
- FAMCRU Ukwanda School for Rural Health
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Cape Town, 남아프리카, 7646
- Be Part Yoluntu
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Durban, 남아프리카, 3629
- Durban International Clinical Research Site, Enhancing Care Foundation
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East London, 남아프리카, 5219
- Monti Clinical Research Centre
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Johannesburg, 남아프리카, 1862
- Perinatal HIV Research Unit
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Johannesburg, 남아프리카, 2038
- Wits RHI Shandukani Research Centre CRS
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Johannesburg, 남아프리카, 2112
- Nkanyezi VIDA Research Unit
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Ka-Majosi, 남아프리카, 944
- Khomanani Health Research and Wellness Centre
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KwaDukuza, 남아프리카, 4449
- Clinical Research Institute of South Africa (CRISA)
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Pretoria, 남아프리카, 0087
- The Aurum Institute: Pretoria Clinical Research Centre
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Soshanguve, 남아프리카, 0152
- Setshaba Research Centre
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- Children's National Hospital
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Florida
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Tampa, Florida, 미국, 33612
- University of South Florida
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Georgia
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Atlanta, Georgia, 미국, 30308
- Grady Ponce de Leon Center
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Illinois
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Chicago, Illinois, 미국, 60614
- Ann and Robert H. Lurie Children's Hospital of Chicago
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marano
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Madrid, 스페인, 28041
- Hospital Universitario 12 De Octubre
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Buenos Aires, 아르헨티나, C1141ACG,
- Helios Salud S.A
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Milan, 이탈리아, 20157
- ASST FBF Sacco Ospedale Sacco
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Roma, 이탈리아, 00165
- IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
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Age and body weight at screening:
- Cohort 1: ≥ 12 years to < 18 years weighing ≥ 35 kg.
- Cohort 2: ≥ 6 years to < 12 years weighing ≥ 25 kg to < 35 kg.
- Cohort 3: ≥ 2 years to < 6 years weighing ≥ 10 kg to < 25 kg.
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On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, > 1 tablet or any other formulation a day).
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Documented plasma HIV-1 ribonucleic acid (RNA) levels must be < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is < 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening).
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Plasma HIV-1 RNA levels < 50 copies/mL at screening.
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No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
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The following laboratory parameters at screening:
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Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula.
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Absolute neutrophil count > 0.50 cells/L (> 500 cells/mm3).
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Hemoglobin ≥ 85 g/L (> 8.5 g/dL).
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Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3).
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Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase)
≤ 5 x upper limit of normal.
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Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).
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Key Exclusion Criteria:
- CD4 cell count < 200 cells/mm^3.
- CD4 percentage < 20%.
- Life expectancy ≤ 1 year.
- An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening.
- Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening.
- Acute hepatitis within 30 days prior to screening.
- Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed).
- Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B virus (HBV) core antibody (antibody against hepatitis B core antigen [anti-HBc]) at screening. If a participant is negative for HBsAg and positive for anti-HBc but HBV DNA is undetectable, the participant may be enrolled.
- A history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN TOS 75/50 mg FDC
Participants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN TOS 75/50 mg starting on Day 1 through Week 48. Following Week 48, participants will have an option to continue BIC/LEN in the extension period. |
Tablets administered orally without regard to food
다른 이름들:
Tablets administered orally without regard to food
다른 이름들:
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실험적: Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kg
All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 2 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period. |
Tablets administered orally without regard to food
다른 이름들:
Tablets administered orally without regard to food |
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실험적: Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kg
All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 3 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period. |
Tablets administered orally without regard to food
다른 이름들:
Tablets administered orally without regard to food |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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24주차까지 치료로 인한 부작용(TEAE)을 경험한 참가자의 비율
기간: 첫 번째 투여일은 24주차까지입니다.
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첫 번째 투여일은 24주차까지입니다.
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24주차까지 치료로 인한 실험실 이상을 경험한 참가자의 비율
기간: 첫 번째 투여일은 24주차까지입니다.
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첫 번째 투여일은 24주차까지입니다.
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PK Parameter: Cmax of BIC and LEN at Steady State
기간: Day 1 up to Week 24, as appropriate
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Cmax is defined as the maximum observed concentration of drug at steady state. |
Day 1 up to Week 24, as appropriate
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PK Parameter: AUCtau of BIC and LEN at Steady State
기간: Day 1 up to Week 24, as appropriate
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AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state. |
Day 1 up to Week 24, as appropriate
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PK Parameter: Ctrough of BIC and LEN at Steady State
기간: Day 1 up to Week 24, as appropriate
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Ctrough is defined as the observed drug concentration at the end of the dosing interval at steady state. |
Day 1 up to Week 24, as appropriate
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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48주차까지 TEAE를 경험한 참가자의 비율
기간: 첫 번째 투여일은 48주차까지입니다.
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첫 번째 투여일은 48주차까지입니다.
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48주차까지 치료로 인한 실험실 이상을 경험한 참가자의 비율
기간: 첫 번째 날짜는 48주차까지입니다.
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첫 번째 날짜는 48주차까지입니다.
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미국 식품의약국(FDA)이 정의한 스냅샷 알고리즘을 기준으로 24주차에 혈장 HIV-1 RNA가 50개 사본/mL 미만 및 50개 사본/mL 이상인 참가자 비율
기간: 24주차
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24주차
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미국 FDA가 정의한 스냅샷 알고리즘을 기준으로 48주차에 혈장 HIV-1 RNA가 50개 사본/mL 미만 및 50개 사본/mL 이상인 참가자 비율
기간: 48주차
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48주차
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24주차에 분화 클러스터 4(CD4) 세포 수의 기준선 대비 변화
기간: 기준선, 24주차
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기준선, 24주차
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24주차 CD4 비율의 기준선 대비 변화
기간: 기준선, 24주차
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기준선, 24주차
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48주차 CD4 세포 수의 기준선 대비 변화
기간: 기준선, 48주차
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기준선, 48주차
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48주차 CD4 비율의 기준선 대비 변화
기간: 기준선, 48주차
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기준선, 48주차
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PK Parameter: AUClast for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration at steady state. |
Day 1 up to Week 48, as appropriate
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PK Parameter: Tmax for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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Tmax is defined as the time (observed time point) of Cmax at steady state. |
Day 1 up to Week 48, as appropriate
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PK Parameter: Tlast for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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Tlast is defined as the time (observed time point) of Clast at steady state. Clast is defined as the last measurable concentration (above the quantification limit). |
Day 1 up to Week 48, as appropriate
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PK Parameter: T1/2 for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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T1/2 is defined as the terminal elimination half-life at steady state. |
Day 1 up to Week 48, as appropriate
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PK Parameter: CL for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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Clearance (CL) is the volume of plasma cleared of drug over a specified time period, at a steady state. |
Day 1 up to Week 48, as appropriate
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PK Parameter: Vz for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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Volume of distribution (Vz) is defined as the extent to in which the drug is distributed in the body tissue, rather than the plasma, to produce the desired effects at a steady state. |
Day 1 up to Week 48, as appropriate
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PK Parameter: λz for BIC and LEN at Steady State
기간: Day 1 up to Week 48, as appropriate
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λz is defined as the terminal elimination rate constant, which determines the rate at which the drug will be eliminated from the body after it is absorbed and distributed at a steady state. |
Day 1 up to Week 48, as appropriate
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Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 1 Assessed by Questionnaire
기간: Day 1
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Day 1
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Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 2 Assessed by Questionnaire
기간: Day 2
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Day 2
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Acceptability and Palatability Summary of Oral BIC/LEN Fixed Dose Combination (FDC) at Day 1 Assessed by Questionnaire
기간: Day 1
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Day 1
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Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 4 Assessed by Questionnaire
기간: Week 4
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Week 4
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Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 24 Assessed by Questionnaire
기간: Week 24
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Week 24
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Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 48 Assessed by Questionnaire
기간: Week 48
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Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. |
Week 48
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Gilead Study Director, Gilead Sciences
간행물 및 유용한 링크
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
- GS-US-621-6463
- 2023-509428-16 (기타 식별자: European Medicines Agency)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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