NCT02275780 — drugset

Summary

To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1. Eligible participants who are deriving benefit will continue in Study Extension 2 to receive the doravirine-containing regimen open label until doravirine becomes locally available or for an additional 96 weeks, whichever comes first. The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48. If non-inferiority is established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be assessed.

Timeline

Start: 2014-12-01
Primary completion: 2016-09-29
Completion: 2023-03-06

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Darunavir	Small molecule	800 mg	Oral
Subject	Doravirine	Small molecule	100 mg	Oral
Comparator	Ritonavir	Other / unclassified	100 mg	Oral
Background	Abacavir	Other / unclassified	600 mg	Oral
Background	Lamivudine	Other / unclassified	300 mg	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral

Indications

No indication recorded.

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

Summary

Timeline

Publications

Drugs

Indications