None listed
Conditions
Interventions
Islatravir +ART Type of group
Islatravir, Capsule 0.75 mg, Once daily, Oral administration, Day 1 to Day 7 + ART + Islatravir, 0.75 mg + Doravirine, 100 mg, Tablet Once daily, Oral administration, Day 8 to week 49
Group name:Placebo + ART Type of group
Placebo, Capsule or Tablet, Once daily, Oral administration, Day 1 to Day 7 + ART + Placebo, Tablet, Once daily, Oral administration, Day 2 to week 49
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at the Screening Visit and confirmed upon repeat testing (Visit 2 [or Visit 3 if required]) during the Run-in period 2. Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form 3. Has at least triple-class resistance (NRTI, NNRTI, and resistance to at least 1 other class [ie, resistance to at least 1 drug in each class]) based on resistance testing at the Screening Visit 4. Has ≤1 fully active antiretroviral remaining that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant 5. Is male or female, from 12 years of age inclusive, and weighing ≥35 kg, at the time of signing the informed consent/assent (the Screening Visit). 6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: -Is not a woman of childbearing potential (WOCBP) OR -Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle 7. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research Please refer to the protocol for more information
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 HBV co-infection (defined as HBsAg-positive or HBV DNA positive) and is not currently being treated for HBV 4. Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration 5. Is taking or is anticipated to require any of the prohibited therapies outlined in Section 6.5 from the Screening Visit and throughout the study treatment period. (See Table 3 footnote for special considerations in Part 2 of the study). See protocol 6. Is taking DOR as part of his/her current failing antiretroviral regimen 7. Is taking EFV, etravirine, or nevirapine 8. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period. 9. Has exclusionary laboratory values (based on central laboratory results) at the Screening Visit as listed in Table 1 (See protocol) 10. Is female and is expecting to conceive or donate eggs at any time during the study Please refer to the protocol for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Miettinen and Nurminen method Measure:Percentage of participants achieving ≥0.5 log10 decrease in HIV-1 RNA from study baseline (Day 1) to Day 8 in the DOR/ISL group Timepoints:Day 8 ; Outcome name:Clopper Pearson method Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs Timepoints:From the time of intervention allocation/ randomization through 42 days after last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Miettinen and Nurminen method Measure:Percentage of participants achieving ≥0.5 log10 decrease in HIV-1 RNA from study baseline (Day 1) to Day 8 in the ISL group and DOR group Timepoints:Day 8 ; Outcome name:Miettinen and Nurminen method Measure:Percentage of participants achieving ≥0.5 log10 decrease in HIV-1 RNA from study baseline (Day 1) and Part 2 baseline (Day 8) to Week 25 and Week 49 Timepoints:Week 25 and Week 49 ; Outcome name:Miettinen and Nurminen method Measure:Percentage of participants achieving ≥1.0 log10 decrease in HIV-1 RNA from study baseline (Day 1) to Day 8, Week 25, and Week 49, and from Part 2 baseline (Day 8) to Week 25 and Week 49 Timepoints:Day 8, Week 25 and Week 49 ; Outcome name:Clopper Pearson method Measure:Percentage of participants with HIV-1 RNA <200 copies/mL, <50 copies/mL, and <40 copies/mL at Week 25 and Week 49 Timepoints:Week 25 and Week 49 ; Outcome name:ANCOVA Measure:Mean change in HIV-1 RNA from study baseline (Day 1) to Day 8, Week 25, and Week 49 and from Part 2 baseline (Day 8) to Week 25 and Week 49 Timepoints:Day 8, Week 25 and Week 49 ; Outcome name:Descriptive statistics including point estimates Measure:Mean change in CD4+ T-cell count from study baseline (Day 1) and Part 2 baseline (Day 8) to Week 25 and Week 49 Timepoints:Week 25 and Week 49 | — |
Countries
Australia, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea South, Mexico, Portugal, Russian Federation, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed