drugset

drugset / Trial / NCT02273765

Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

NCT02273765 ↗

Phase 3 Completed 460 enrolled ANRS, Emerging Infectious Diseases Merck Sharp & Dohme LLC · collab Ministry of Health, Brazil · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.

Timeline

Start: 2015-09-11
Primary completion: 2018-11-28
Completion: 2018-11-28

Publications

De Castro N, Marcy O, Chazallon C, Messou E, Eholie S, N'takpe JB, Bhatt N, Khosa C, Timana Massango I, Laureillard D, Chau GD, Domergue A, Veloso V, Escada R, Wagner Cardoso S, Delaugerre C, Anglaret X, Molina JM, Grinsztejn B; ANRS 12300 Reflate TB2 study group. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial. Lancet Infect Dis. 2021 Jun;21(6):813-822. doi: 10.1016/S1473-3099(20)30869-0. Epub 2021 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	600 mg	—
Comparator	Raltegravir	Other / unclassified	400 mg	—
Background	Lamivudine	Other / unclassified	300 mg	—
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	—

Indications