Trials / Completed
CompletedNCT04233216
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
Detailed description
Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo. Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISL | ISL 0.75 mg capsule taken by mouth. |
| DRUG | DOR | DOR 100 mg tablet taken by mouth. |
| DRUG | DOR/ISL | 100 mg DOR/0.75 mg ISL FDC taken by mouth. |
| DRUG | Placebo to ISL | Placebo capsule matched to ISL taken by mouth. |
| DRUG | Placebo to DOR | Placebo tablet matched to DOR taken by mouth. |
Timeline
- Start date
- 2020-03-18
- Primary completion
- 2022-11-21
- Completion
- 2023-11-01
- First posted
- 2020-01-18
- Last updated
- 2024-12-27
- Results posted
- 2023-12-08
Locations
98 sites across 18 countries: United States, Australia, Canada, Chile, Colombia, France, Germany, Italy, Japan, Peru, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04233216. Inclusion in this directory is not an endorsement.