HIV-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Sponsors
Merck Sharp & Dohme LLC
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 28
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 an active diagnosis of hepatitis due to any cause, including active HBV coinfection (defined as HBsAg-positive or HBV DNA positive) 4.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 5.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 6.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 7.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 8.Has a documented or known virologic resistance to DOR, as demonstrated by any of the following DOR resistance substitutions in reverse transcriptase: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L, or Y318F 9.Has exclusionary laboratory values (completed by the central laboratory) within 45 days prior to Day 1 10.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 following switch to Doravirine/Islatravir (DOR/ISL) compared to continued treatment with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with Human Immunodeficiency Virus 1 (HIV-1) RNA =50 copies/mL at Week 48 2.To evaluate the safety and tolerability of switch to DOR/ISL compared to continued treatment with BIC/FTC/TAF as assessed by review of the accumulated safety data through Week 48;Secondary Objective: 1. To evaluate the antiretroviral activity as assessed by the percentage of participants with HIV-1 RNA >50 copies/mL at Week 96 2. To evaluate the antiretroviral activity as assessed by the percentage of participants with HIV-1 RNA >50 copies/mL at Week 144 3. To evaluate the antiretroviral activity as assessed by the percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48 4. To evaluate the antiretroviral activity as assessed by the percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 5. To evaluate the antiretroviral activity as assessed by the percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 6. To evaluate the immunologic effect as measured by change from baseline in CD4+ T-cell count at Weeks 48, 96 and 144 7. To evaluate the development of viral drug resistance 8. To evaluate the effect on body weight to Weeks 48, 96 and 144 9. To evaluate the safety and tolerability through Week 144;Primary end point(s): 1.Percentage of participants with HIV-1 RNA =50 copies/mL at Week 48 2.Percentage of participants with one or more adverse events (AEs) up to Week 48 3.Percentage of participants who discontinued study intervention due to an AE up to Week 48;Timepoint(s) of evaluation of this end point: 1. Week 48 2. Week 48 3. Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants with HIV-1 RNA >50 copies/mL at Week 96 2. Percentage of participants with HIV-1 RNA >50 copies/mL at Week 144 3. Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48 4. Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 5. Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 6. Change from baseline in CD4+ T-cell count at Week 48 7. Change from baseline in CD4+ T-cell count at Week 96 8. Change from baseline in CD4+ T-cell count at Week 144 9.Percentage of participants with viral drug resistance-associated substitutions at Week 48 10. Percentage of participants with viral drug resistance-associated substitutions at Week 96 11. Percentage of participants with viral drug resistance-associated substitutions at Week 144 12. Change from baseline in body weight at Week 48 13. Change from baseline in body weight at Week 96 14. Change from baseline in body weight at Week 144 15. Percentage of participants with one or more AEs up to Week 144 16. Percentage of participants who discontinued study intervention due to an AE up to Week 144;Timepoint(s) of evaluation of this end point: 1. Week 96 2. Week 144 3. Week 48 4. Week 96 5. Week 144 6. Baseline and Week 48 7. Baseline and Week 96 8. Baseline and Week 144 9. Week 48 10. Week 96 11. Week 144 12. Baseline and Week 48 13. Baseline and Week 96 14. Baseline and Week 144 15. Week 144 16. Week 144 | — |
Countries
Australia, Austria, Canada, Finland, France, Germany, Italy, Japan, Puerto Rico, Spain, United States
Contacts
Public ContactRebeca Milanesi Plank
Merck Sharp & Dohme LLC
Outcome results
None listed