National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

Phase 3 Completed 101 enrolled ANRS, Emerging Infectious Diseases Institut National de la Santé Et de la Recherche Médicale, France · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.

Timeline

Start: 2017-04-11
Primary completion: 2019-07-30
Completion: 2020-01-31

Publications

Results Cheret A, Bauer R, Meiffredy V, Lopez P, Ajana F, Lacombe K, Morlat P, Lascoux C, Reynes J, Calin R, Abel S, Goujard C, Rouzioux C, Avettand-Fenoel V, Meyer L. Once-daily dolutegravir versus darunavir plus cobicistat in adults at the time of primary HIV-1 infection: the OPTIPRIM2-ANRS 169 randomized, open-label, Phase 3 trial. J Antimicrob Chemother. 2022 Aug 25;77(9):2506-2515. doi: 10.1093/jac/dkac207.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cobicistat	Small molecule	150 mg	Oral
Comparator	Darunavir	Small molecule	800 mg	Oral
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Background	Tenofovir	Small molecule	245 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral

National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

Summary

Timeline

Publications

Drugs

Indications