HIV-1-Infection
Conditions
Interventions
Experimental: Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF
- Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to
Sponsors
Kondo Akira
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV-1 RNA = 6 months before screening, as documented by: 1. One HIV-1 RNA = 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits. Plasma HIV-1 RNA levels = 6 months prior to screening and willing to continue until Day 1. Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
Exclusion criteria
Exclusion criteria: Prior virologic failure. Prior use of, or exposure to ISL or LEN. Active, serious infections requiring parenteral therapy within 30 days before randomization. Active tuberculosis infection. Acute hepatitis within 30 days before randomization. Hepatitis B virus (HBV) infection as determined below at the screening visit: 1. Positive HBV surface antigen OR 2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination. Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled. Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) 5 x upper limit of normal (ULN) 3. Direct bilirubin > 1.5 x ULN 4. Platelets < 50,000/uL 5. Hemoglobin < 8.0 g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants with HIV-1 RNA >= 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm [Time Frame: Week 48] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants With HIV-1 RNA >= 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96] Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 and Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 48, Week 96] Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48 and Week96 [Time Frame: Week 48, Week96] Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 up to Week 48] | — |
Countries
Argentina, Australia, Canada, France, Germany, Japan, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, US
Contacts
Public ContactOperations Clinical
Gilead Sciences K.K.
Outcome results
None listed