HIV-1-Infection
Conditions
Brief summary
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
Interventions
DRUGISL/LEN
Tablet administered orally
2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.
Sponsors
Merck Sharp & Dohme LLC
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 weeks 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. * Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96. * 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 (ALT) \> 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 Week 48 as Determined by the US FDA-defined Snapshot Algorithm | Week 48 |
| Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 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 Week 96 | Baseline, Week 96 |
| Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs) | First dose date up to Week 96 |
| Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48 | Baseline, Week 48 |
Countries
Argentina, Australia, Germany, Japan, Netherlands, Poland, Puerto Rico, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
Outcome results
None listed