DOR/ISL 100 mg/0.25 mg QD Open-Label Switch

JRCT ID: jRCT2031220698

Registered date:14/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: HIV-1 Infection
• Date of first enrollment: 27/04/2023
• Target sample size: 501
• Countries of recruitment: USA,Japan,Canada,Japan,Colombia,Japan,France,Japan,Italy,Japan,UK,Japan,Spain,Japan,Switzerland,Japan,South Africa,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

- Switch from baseline ART to DOR/ISL(100 mg/0.25 mg QD) on Day 1 and continue DOR/ISL QD through Week 96
OR
- Continue baseline ART until Week 48 and switch to DOR/ISL (100 mg/0.25 mg QD) from Week 48 through Week 96

Outcome(s)

Primary Outcome

1. Percentage of participants with HIV-1 RNA >=50 copies/mL at Week 48
2. Percentage of participants with one or more AEs from Day 1 up to Week 48
3. Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 48

Secondary Outcome

1. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
2. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
3. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
4. Percentage of participants with HIV-1 RNA >=50 copies/mL at Week 96
5. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
6. Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48
7. Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96
8. Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96
9. Number of participants with viral resistance-associated substitutions
10. Mean change from Baseline to Week 48 in fasting LDL-C
11. Mean change from baseline to Week 48 in fasting HDL-C
12. Percentage of participants with one or more AEs from Day 1 up to Week 96
13. Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 96
14. Percentage of participants with one or more AEs from Week 48 up to Week 96
15. Percentage of participants with an AE leading to discontinuation of study intervention from Week 48 up to Week 96

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
-Has been receiving continuous, stable oral 2-drug or 3-drug combination (+- PK booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for >=3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
-Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator

Exclude criteria

-Has HIV-2 infection
-Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
-Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
-Has active hepatitis B virus (HBV) infection
-Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
-Has a <=5 years prior history of malignancy
-Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
-Has taken long-acting HIV therapy at any time
-Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
-Has a documented or known virologic resistance to DOR

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05631093