A clinical study of people with HIV-1 who received prior treatment combination of doravirine and islatravir

Phase 1

Conditions: HIV-1 infection
MedDRA version: 20.1Level: LLTClassification code: 10068341Term: HIV-1 infection Class: 10021881
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: CTIS2022-502126-40-00

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1312

Inclusion 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]).

Exclusion 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of DOR/ISL (100 mg/0.25 mg) as assessed by accumulated safety data through Week 96;Secondary Objective: To evaluate the antiretroviral activity of DOR/ISL (100 mg/0.25 mg) as assessed by the percentage of participants with the following at Week 96: •HIV-1 RNA =50 copies/mL •HIV-1 RNA <50 copies/mL •HIV-1 RNA =200 copies/mL, To evaluate the development of viral resistance to DOR/ISL (100 mg/0.25 mg);Primary end point(s): Percentage of participants with one or more adverse events, Percentage of participants who discontinue study intervention due to adverse events

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Percentage of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 96;Secondary end point(s):Percentage of participants with HIV-1 RNA =50 copies/mL at Week 96;Secondary end point(s):Percentage of participants with HIV-1 RNA =200 copies/mL at Week 96;Secondary end point(s):Percentage of participants with evidence of viral drug resistance-associated substitutions