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임상시험 NCT07266831은(는) Human Immunodeficiency Virus Type 1 (HIV-1) Infection에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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머크A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) 2상, 3상 570
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07266831은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Human Immunodeficiency Virus Type 1 (HIV-1) Infection에 대해 진행되며, 2상 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 12월 18일에 시작되어 570명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2030년 4월 3일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a stu...더 보기
공식 제목
A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1
질환명
Human Immunodeficiency Virus Type 1 (HIV-1) Infection기타 연구 식별자
- 8591B-062
- U1111-1323-4689 (등록 식별자) (UTN)
- 2025-522519-40 (등록 식별자) (EU CT)
- MK-8591B-062 (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2025-12-18
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2030-04-03
계획된 등록 인원
570
연구종류
중재연구
단계/상
2상
3상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Phase 2: ISL + ULO Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks | ISL ISL 2 x 1 mg oral capsules administered qw for 96 weeks ULO ULO 2 x 100 mg oral tablets administered qw for 96 weeks |
활성 대조군Phase 2: BIC/FTC/TAF Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks | BIC/FTC/TAF BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks |
실험적Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks | Placebo for BIC/FTC/TAF BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks ISL/ULO ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks |
활성 대조군Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks | BIC/FTC/TAF BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks Placebo to ISL/ULO ISL/ULO-matching placebo oral tablets administered qw for 96 weeks |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 | Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24. | Week 24 |
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 24 |
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 24 |
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48. | Week 48 |
Phase 3: Percentage of Participants Who Experience an AE at Week 48 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 48 |
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 48 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48. | Week 48 |
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96. | Week 96 |
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 24. | Week 24 |
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48. | Week 48 |
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96. | Week 96 |
Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 24 weeks. | Baseline (Day 1) and Week 24 |
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks. | Baseline (Day 1) and Week 48 |
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks. | Baseline (Day 1) and Week 96 |
Phase 2: Percentage of Participants Who Experience an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 102 weeks |
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 96 weeks |
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 24 will be presented. | Week 24 |
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented. | Week 48 |
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented. | Week 96 |
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96. | Week 96 |
Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48. | Week 48 |
Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96. | Week 96 |
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks. | Baseline (Day 1) and Week 48 |
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks. | Baseline (Day 1) and Week 96 |
Phase 3: Percentage of Participants Who Experience an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 102 weeks |
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 96 weeks |
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented. | Week 48 |
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented. | Week 96 |
Phase 3: Mean Change From Baseline in Body Weight at Week 48 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 48 |
Phase 3: Mean Change From Baseline in Body Weight at Week 96 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 96 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
- Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
- Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3.
- Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
- Has human immunodeficiency virus type 2 (HIV-2) infection.
- Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
- Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
- Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
29 4개국에 임상시험 장소
Colorado
Vivent Health ( Site 1519), Denver, Colorado, 80246, United States
Study Coordinator, 연락처, 303-393-8050
모집중
District of Columbia
Whitman-Walker Institute ( Site 1538), Washington D.C., District of Columbia, 20032, United States
Study Coordinator, 연락처, 202-207-2510
모집중
Florida
Midway Immunology and Research Center ( Site 1503), Ft. Pierce, Florida, 34982, United States
Study Coordinator, 연락처, 772-595-9830
모집중
CAN Community Health- Miami Gardens ( Site 1549), Miami, Florida, 33055, United States
Study Coordinator, 연락처, 954-955-0023
모집중
Orlando Immunology Center ( Site 1501), Orlando, Florida, 32803, United States
Study Coordinator, 연락처, 407-374-0220
모집중
CAN Community Health ( Site 1510), Sarasota, Florida, 34237, United States
Study Coordinator, 연락처, 941-366-0134
모집중
Triple O Research Institute ( Site 1505), West Palm Beach, Florida, 33407, United States
Study Coordinator, 연락처, 561-855-7871
모집중
Georgia
Metro Infectious Diseases Consultants L.L.C. ( Site 1509), Decatur, Georgia, 30033, United States
Study Coordinator, 연락처, 404-297-9755
모집중
Mercer university, Department of internal medicine-Clinical Research ( Site 1512), Macon, Georgia, 31201, United States
Study Coordinator, 연락처, 478-301-5846
모집중
Missouri
KC CARE Health Center ( Site 1506), Kansas City, Missouri, 64111, United States
Study Coordinator, 연락처, 816-753-5144
모집중
New Jersey
ID Care ( Site 1507), Hillsborough, New Jersey, 08844, United States
Study Coordinator, 연락처, 908-281-0221
모집중
North Carolina
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533), Charlotte, North Carolina, 28204, United States
Study Coordinator, 연락처, 704-468-3510
모집중
Regional Center for Infectious Diseases ( Site 1516), Greensboro, North Carolina, 27401, United States
Study Coordinator, 연락처, 336-832-3275
모집중
Ohio
The Ohio State University ( Site 1536), Columbus, Ohio, 43210, United States
Study Coordinator, 연락처, 614-293-8112
모집중
Pennsylvania
University of Pennsylvania Perelman School of Medicine ( Site 1508), Philadelphia, Pennsylvania, 19104, United States
Study Coordinator, 연락처, 215-349-8092
모집중
Texas
Saint Hope Foundation, Inc. ( Site 1504), Bellaire, Texas, 77401, United States
Study Coordinator, 연락처, 713-839-7111
모집중
Prism Health North Texas, Oak Cliff Health Center ( Site 1514), Dallas, Texas, 75208, United States
Study Coordinator, 연락처, 214-521-5191
모집중
North Texas Infectious Diseases Consultants ( Site 1500), Dallas, Texas, 75246, United States
Study Coordinator, 연락처, 214-276-5627
모집중
Texas Center for Infectious Disease Associates ( Site 1502), Fort Worth, Texas, 76104, United States
Study Coordinator, 연락처, 817-348-0042
모집중
DCOL Center for Clinical Research ( Site 1511), Longview, Texas, 75605, United States
Study Coordinator, 연락처, 903-238-8854
모집중
British Columbia
Spectrum Health ( Site 3307), Vancouver, British Columbia, V6Z 2T1, Canada
Study Coordinator, 연락처, 6046853747
모집중
Quebec
Gestion clinique médicale l'Actuel ( Site 3303), Montreal, Quebec, H2L 4P9, Canada
Study Coordinator, 연락처, 5145243642x2271
모집중
Gironde
Bordeaux University Hospital - Pellegrin ( Site 3605), Bordeaux, Gironde, 33000, France
Study Coordinator, 연락처, +33556795536
모집중
Pays de la Loire Region
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606), Nantes, Pays de la Loire Region, 44093, France
Study Coordinator, 연락처, +33240083109
모집중
Rhone
HOPITAL DE LA CROIX ROUSSE ( Site 3613), Lyon, Rhone, 69317, France
Study Coordinator, 연락처, +33472071107
모집중
Île-de-France Region
Hôpital Bichat - Claude-Bernard ( Site 3601), Paris, Île-de-France Region, 75018, France
Study Coordinator, 연락처, +33140257803
모집중
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801), Guatemala City, 01009, Guatemala
Study Coordinator, 연락처, +50223196600
모집중
MEDI-K ( Site 3803), Guatemala City, 01009, Guatemala
Study Coordinator, 연락처, +50222912323
모집중
CELAN,S.A ( Site 3802), Guatemala City, 01010, Guatemala
Study Coordinator, 연락처, +50222968018
모집중