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 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 289
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 co-infection (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 taking long-acting cabotegravir-rilpivirine 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 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 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 following switch to Doravirine/Islatravir (DOR/ISL) compared to continued baseline antiretroviral therapy (ART) 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 baseline ART as assessed by review of the accumulated safety data through Week 48;Secondary Objective: 1. To evaluate the antiretroviral activity at Week 48 2. To evaluate the antiretroviral activity at Week 96 3. To evaluate the sustained antiretroviral activity in participants who switched to DOR/ISL on Day 1 at Week 96 4. To evaluate the immunologic effect of switch to DOR/ISL as measured by change from baseline in CD4+ T-cell count at Week 48 5. To evaluate the immunologic effect of DOR/ISL as assessed by the change from baseline in CD4+ T-cell count at Week 96 6. To evaluate the development of viral drug resistance 7. To evaluate the effect on fasting lipid profiles following switch to DOR/ISL compared to continued baseline ART 8. To evaluate the effect of switch to DOR/ISL compared to continued baseline ART on weight 9. To evaluate the safety and tolerability of DOR/ISL through Week 96;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 <40 or <50 copies/mL at Week 48 2. Percentage of participants with HIV-1 RNA =50 copies/mL, <40 copies/mL or <50 copies/mL from Week 48 to Week 96 3. Percentage of participants with HIV-1 RNA =50 copies/mL, <40 copies/mL or <50 copies/mL from Day 1 to Week 96 4. Change from baseline in CD4+ T-cell count at Week 48 5. Change from baseline in CD4+ T-cell count at Week 96 6. Change from Week 48 in CD4+ T-cell count at Week 96 7. Percentage of participants with evidence of viral drug resistance associated substitutions at Week 48 8. Percentage of participants with evidence of viral drug resistance-associated substitutions at Week 96 9. Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 24 10. Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48 11. Change from baseline in body weight at Week 48 12. Percentage of participants with one or more AEs from Day 1 up to Week 96 13. Percentage of participants who discontinued study intervention due to an AE from Day 1 up to Week 96 14. Percentage of participants with one or more AEs from Week 48 up to Week 96 15. Percentage of participants who discontinued study intervention due to an AE from Week 48 up to Week 96;Timepoint(s) of evaluation of this end point: 1. Week 48 2. Weeks 48 to 96 3. Day 1 to Week 96 4. Baseline and Week 48 5. Baseline and Week 96 6. Week 48 and Week 96 7. Week 48 8. Week 96 9. Baseline and Week 24 10. Baseline and Week 48 11. Baseline and Week 48 12. Day 1 to Week 96 13. Day 1 to Week 96 14. Weeks 48 to 96 15. Weeks 48 to 96 | — |
Countries
Australia, Canada, Chile, Colombia, France, Italy, Japan, New Zealand, Poland, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactTodd Alan Correll
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Outcome results
None listed