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治験 NCT07266831（対象：Human Immunodeficiency Virus Type 1 (HIV-1) Infection）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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MSDA Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) 第II相・フェーズ2, 第III相・フェーズ3 570
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07266831 は Human Immunodeficiency Virus Type 1 (HIV-1) Infection に関する 治療 の研究で、第II相・フェーズ2 第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2025年12月18日 から開始しています。570 名の参加者 の募集が計画されています。この試験は MSD によって主導され、2030年4月3日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
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...もっと見る
公式タイトル
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
疾患名
Human Immunodeficiency Virus Type 1 (HIV-1) Infectionその他の研究識別子
- 8591B-062
- U1111-1323-4689 (登録識別子) (UTN)
- 2025-522519-40 (登録識別子) (EU CT)
- MK-8591B-062 (その他の識別子) (MSD)
NCT番号
開始日
2025-12-18
最終更新日
2026-03-27
終了予定日
2030-04-03
目標参加者数
570
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
第III相・フェーズ3
第III相・フェーズ3
状況
募集中
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Phase 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 |
実薬対照薬Phase 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 |
実験的Phase 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 |
実薬対照薬Phase 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 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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.
MSD試験中央連絡先
連絡先: Toll Free Number, 1-888-577-8839, [email protected]
29 4カ国の場所
Colorado
Vivent Health ( Site 1519), Denver, Colorado, 80246, United States
Study Coordinator, 連絡先, 303-393-8050
募集中
District of Columbia
Whitman-Walker Institute ( Site 1538), Washington D.C., District of Columbia, 20032, United States
Study Coordinator, 連絡先, 202-207-2510
募集中
Florida
Midway Immunology and Research Center ( Site 1503), Ft. Pierce, Florida, 34982, United States
Study Coordinator, 連絡先, 772-595-9830
募集中
CAN Community Health- Miami Gardens ( Site 1549), Miami, Florida, 33055, United States
Study Coordinator, 連絡先, 954-955-0023
募集中
Orlando Immunology Center ( Site 1501), Orlando, Florida, 32803, United States
Study Coordinator, 連絡先, 407-374-0220
募集中
CAN Community Health ( Site 1510), Sarasota, Florida, 34237, United States
Study Coordinator, 連絡先, 941-366-0134
募集中
Triple O Research Institute ( Site 1505), West Palm Beach, Florida, 33407, United States
Study Coordinator, 連絡先, 561-855-7871
募集中
Georgia
Metro Infectious Diseases Consultants L.L.C. ( Site 1509), Decatur, Georgia, 30033, United States
Study Coordinator, 連絡先, 404-297-9755
募集中
Mercer university, Department of internal medicine-Clinical Research ( Site 1512), Macon, Georgia, 31201, United States
Study Coordinator, 連絡先, 478-301-5846
募集中
Missouri
KC CARE Health Center ( Site 1506), Kansas City, Missouri, 64111, United States
Study Coordinator, 連絡先, 816-753-5144
募集中
New Jersey
ID Care ( Site 1507), Hillsborough, New Jersey, 08844, United States
Study Coordinator, 連絡先, 908-281-0221
募集中
North Carolina
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533), Charlotte, North Carolina, 28204, United States
Study Coordinator, 連絡先, 704-468-3510
募集中
Regional Center for Infectious Diseases ( Site 1516), Greensboro, North Carolina, 27401, United States
Study Coordinator, 連絡先, 336-832-3275
募集中
Ohio
The Ohio State University ( Site 1536), Columbus, Ohio, 43210, United States
Study Coordinator, 連絡先, 614-293-8112
募集中
Pennsylvania
University of Pennsylvania Perelman School of Medicine ( Site 1508), Philadelphia, Pennsylvania, 19104, United States
Study Coordinator, 連絡先, 215-349-8092
募集中
Texas
Saint Hope Foundation, Inc. ( Site 1504), Bellaire, Texas, 77401, United States
Study Coordinator, 連絡先, 713-839-7111
募集中
Prism Health North Texas, Oak Cliff Health Center ( Site 1514), Dallas, Texas, 75208, United States
Study Coordinator, 連絡先, 214-521-5191
募集中
North Texas Infectious Diseases Consultants ( Site 1500), Dallas, Texas, 75246, United States
Study Coordinator, 連絡先, 214-276-5627
募集中
Texas Center for Infectious Disease Associates ( Site 1502), Fort Worth, Texas, 76104, United States
Study Coordinator, 連絡先, 817-348-0042
募集中
DCOL Center for Clinical Research ( Site 1511), Longview, Texas, 75605, United States
Study Coordinator, 連絡先, 903-238-8854
募集中
British Columbia
Spectrum Health ( Site 3307), Vancouver, British Columbia, V6Z 2T1, Canada
Study Coordinator, 連絡先, 6046853747
募集中
Quebec
Gestion clinique médicale l'Actuel ( Site 3303), Montreal, Quebec, H2L 4P9, Canada
Study Coordinator, 連絡先, 5145243642x2271
募集中
Gironde
Bordeaux University Hospital - Pellegrin ( Site 3605), Bordeaux, Gironde, 33000, France
Study Coordinator, 連絡先, +33556795536
募集中
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, 連絡先, +33240083109
募集中
Rhone
HOPITAL DE LA CROIX ROUSSE ( Site 3613), Lyon, Rhone, 69317, France
Study Coordinator, 連絡先, +33472071107
募集中
Île-de-France Region
Hôpital Bichat - Claude-Bernard ( Site 3601), Paris, Île-de-France Region, 75018, France
Study Coordinator, 連絡先, +33140257803
募集中
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801), Guatemala City, 01009, Guatemala
Study Coordinator, 連絡先, +50223196600
募集中
MEDI-K ( Site 3803), Guatemala City, 01009, Guatemala
Study Coordinator, 連絡先, +50222912323
募集中
CELAN,S.A ( Site 3802), Guatemala City, 01010, Guatemala
Study Coordinator, 連絡先, +50222968018
募集中