Follow-up of Participants Who Received DOR/ISL (100 mg/0.75 mg)

JRCT ID: jRCT2051230002

Registered date:07/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: HIV-1 Infection
• Date of first enrollment: 26/04/2023
• Target sample size: 650
• Countries of recruitment: USA,Japan,Canada,Japan,Argentina,Japan,Chile,Japan,Colombia,Japan,Puerto Rico,Japan,Israel,Japan,Russia,Japan,South Africa,Japan,Switzerland,Japan,UK,Japan,Australia,Japan,New Zealand,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): DOR/ISL (100 mg/0.25 mg) once daily (QD) orally from Day 1 to Week 96.

Outcome(s)

Primary Outcome

1. Percentage of Participants with One or More Adverse Event (AE) [ Time Frame: Up to 102 Weeks ].
2. Percentage of participants who Discontinue Study Intervention Due to an AE [ Time Frame: Up to 96 Weeks ].

Secondary Outcome

1. Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) >=50 copies/mL at Week 96.
2. Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96.
3. Percentage of Participants with HIV-1 RNA >=200 copies/mL at Week 96.
4. Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: '- Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

Exclude criteria

'- Has confirmed HIV-1 RNA >=200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
- Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
- Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05766501