ビクテグラビル/エムトリシタビン/テノホビルアラフェナミド（BIC/FTC/TAF）でウイルス学的抑制が認められたヒト免疫不全ウイルス1型（HIV-1）患者におけるドラビリン/イスラトラビル（DOR/ISL）への切り替え（MK-8591A-052）

基本情報

NCT ID

NCT05630755

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

514

治験依頼者名

Merck Sharp & Dohme LLC

概要

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)