DOR/ISL 100 mg/0.25 mg QD Blinded Switch

JRCT ID: jRCT2051230003

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: 14/04/2023
• Target sample size: 501
• Countries of recruitment: USA,Japan,Chile,Japan,Mexico,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Spain,Japan,UK,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

- Switch from BIC/FTC/TAF QD to DOR/ISL(100 mg/0.25 mg QD) on Day 1 and continue DOR/ISL QD through Week 96 (taken with matching placebo to BIC/FTC/TAF through Week 96)
OR
- Continue BIC/FTC/TAF QD through Week 96 (taken with matching placebo to DOR/ISL (100 mg/0.25 mg QD) 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 who experience AEs through Week 48
3. Percentage of participants who discontinue study intervention due to AEs through Week 48

Secondary Outcome

1. Percentage of participants with HIV-1 RNA >=50 copies/mL at Week 96
2. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
3. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
4. Percentage of participants with HIV-1 RNA <200 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 Day 1 in CD4+ T-cell count at Week 96
8. Number of participants with viral drug resistance mutations at Week 48
9. Number of participants with viral drug resistance mutations at Week 96
10. Percentage of participants who experience AEs through study duration
11. Percentage of participants who discontinue study intervention due to AEs through study duration

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
- Has been receiving BIC/FTC/TAF therapy 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 participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Exclude criteria

- Has HIV-2 infection
- 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 with laboratory values consistent with cirrhosis
- 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 cancer, or cutaneous Kaposi's sarcoma
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Has a documented or known virologic resistance to DOR
- Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
- 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 except those currently enrolled in the comparator arm of an ongoing DOR/ISL study

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05630755