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NCT04233216 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT04233216 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 35 participants.
The verdict
NCT04233216, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study 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).
Interventions
- DRUG ISL
- DRUG DOR/ISL
- DRUG DOR
- DRUG Placebo to ISL
- DRUG Placebo to DOR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04233216
The ClinicalTrials.gov registry entry for NCT04233216 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which ISL is the first listed.
NCT04233216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04233216 about?
NCT04233216 is a clinical study titled "Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)". 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 ...
What is the current status of trial NCT04233216?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2020-03-18. Estimated completion is 2023-11-01.
What interventions are being tested in trial NCT04233216?
The interventions under investigation include: ISL (DRUG), DOR/ISL (DRUG), DOR (DRUG), Placebo to ISL (DRUG), Placebo to DOR (DRUG).
Who is sponsoring clinical trial NCT04233216?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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