Comparison of MK-1439A and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) (DRIVE-AHEAD)
ClinicalTrials.gov ID: NCT02403674
Sponsor: Merck Sharp & Dohme LLC
Information provided by: Merck Sharp & Dohme LLC (Responsible Party)
Last Update Posted: 2023-10-10
Brief Summary:
The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week double-blind period and a 96-week open-label period. The present results are based on the first 48 weeks of this ongoing study.
Detailed Description:
Participants in Australia, Colombia, Guatemala, Honduras, Israel, New Zealand, Peru, Russia, South Africa, and Thailand who are deriving benefit from doravirine, tenofovir, lamivudine are also eligible to continue receiving study drug during additional open-label extensions which will last for 2 years or until drug is available locally, whichever comes first.
Official Title:
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
Intervention / Treatment:
- Drug: Doravirine, Tenofovir, Lamivudine
- Drug: ATRIPLA™
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2015-06-05 |
| Primary Completion (Actual) | 2017-03-20 |
| Study Completion (Actual) | 2023-09-07 |
| Enrollment (Actual) | 734 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
1439A-021
MK-1439A-021 (Other Identifier) (OTHER: Merck Protocol Number) 2014-003382-17 (EudraCT Number) |