HIV-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Islatravir
Product Code: MK-8591
Pharmaceutical Form: Capsule
INN or Proposed INN: MK-8591
Current Sponsor code: MK-8591
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is HIV-1 positive with plasma HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Has HIV-2 infection 2. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator 3. Has active HCV coinfection (defined as detectable HCV RNA) or HBV coinfection (defined as HBsAg-positive or HBV DNA positive) (completed by the central laboratory) 4. Has a current (active) diagnosis of acute hepatitis due to any cause 5. Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma 6. Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate 7. Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 45 days prior to Day 1 through the study treatment period 8. Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period 9. Has a documented or known virologic resistance to: - any of the following MK-8507 or NNRTI resistance-associated substitutions in reverse transcriptase: L100I, K101E, K101P, K103N, K103S, V106A, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190E, G190S, H221Y, P225H, F227C, F227L, F227V, M230I, M230L, L234I, Y318F - any of the following NRTI resistance-associated substitutions in reverse transcriptase: M184I, M184V 10. Has exclusionary laboratory values (completed by the central laboratory) within 45 days prior to Day 1 11. Is female and expecting to conceive or donate eggs at any time during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the antiretroviral activity of islatravir (ISL) administered with different doses of MK-8507 once-weekly after switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) compared to continued treatment with BIC/FTC/TAF once-daily as assessed by the percentage of participants with human immunodeficiency virus type 1 ( HIV-1) ribonucleic acid (RNA) =50 copies/mL at Week 48 2. To evaluate the safety and tolerability of ISL + MK-8507 once weekly as assessed by review of the accumulated safety data;Secondary Objective: 1. Antiretroviral (antiRTV) activity of switch to ISL + MK-8507 vs continued BIC/FTC/TAF treatment at Week 48 2. AntiRTV activity of switch to ISL + MK-8507 vs continued BIC/FTC/TAF treatment at Week 24 3. AntiRTV suppression of switch to ISL + MK-8507 vs continued BIC/FTC/TAF treatment at Week 96 4. Immunologic effect of switch to ISL + MK-8507 vs continued BIC/FTC/TAF treatment based on change from baseline in CD4+ T-cells Weeks 24, 48, and 96 5. AntiRTV suppression & immunologic effect of ISL + MK-8507 based on % with HIV-1 RNA =50 copies/mL & change from baseline in CD4+ T-cell count at Week 144 6. Development of viral drug resistance of switch to ISL + MK-8507 vs continued BIC/FTC/TAF treatment;Primary end point(s): 1. Percentage of participants with HIV-1 RNA =50 copies/mL 2. Percentage of participants with =1 adverse event (AE) 3. Percentage of participants discontinuing study intervention due to AE;Timepoint(s) of evaluation of this end point: 1. Week 48 2. Up to 96 weeks 3. Up to 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants with HIV-1 RNA <50 copies/mL 2. Percentage of participants with HIV-1 RNA <40 copies/mL 3. Percentage of participants with HIV-1 RNA =50 copies/mL 4. Percentage of participants with HIV-1 RNA <50 copies/mL 5. Percentage of participants with HIV-1 RNA <40 copies/mL 6. Percentage of participants with HIV-1 RNA =50 copies/mL 7. Percentage of participants with HIV-1 RNA <50 copies/mL 8. Percentage of participants with HIV-1 RNA <40 copies/mL 9. Change from BL in CD4+ T-cell count 10. Change from BL in CD4+ T-cell count 11. Change from BL in CD4+ T-cell count 12. Percentage of participants with HIV-1 RNA =50 copies/mL 13. Change from BL in CD4+ T-cell count 14. Incidence of viral drug resistance ;Timepoint(s) of evaluation of this end point: 1. Week 48 2. Week 48 3. Week 24 4. Week 24 5. Week 24 6. Week 96 7. Week 96 8. Week 96 9. Baseline (Day 1) and Week 24 10. Baseline (Day 1) and Week 48 11. Baseline (Day 1) and Week 96 12. Week 144 13. Baseline (Day 1) and Week 144 14. Up to 144 weeks | — |
Countries
France, Switzerland, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed