HIV-1-infection
Conditions
Brief summary
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Interventions
DRUGISL/LEN
Tablet administered orally
DRUGB/F/TAF
Tablet administered orally
DRUGPTM B/F/TAF
Tablet administered orally
DRUGPTM ISL/LEN
Tablet administered orally
Sponsors
Merck Sharp & Dohme LLC
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by: 1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening. 2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL. 3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable (blip), as long as it is not confirmed on 2 consecutive visits. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Individuals are receiving B/F/TAF for ≥ 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. Key
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) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase \> 5 x upper limit of normal (ULN) 3. Direct bilirubin \> 1.5 x ULN 4. Platelets \< 50,000/μL 5. Hemoglobin \< 8.0 g/dL Note: Other protocol defined Inclusion/
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 | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 as Determined by the US FDA-Defined Snapshot Algorithm | Week 48 |
| Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm | Week 96 |
| Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm | Week 96 |
| Change From Baseline in CD4 T-Cell Count at Weeks 96 | Week 96 |
| Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 48 |
| Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48 | Week 48 |
Countries
Argentina, Australia, Canada, France, Germany, Japan, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed