A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

Phase 4 Completed 141 enrolled Fundacion SEIMC-GESIDA

RandomizedParallel-groupOpen-labelTreatment

Summary

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)

Timeline

Start: 2019-10-10
Primary completion: 2023-06-15
Completion: 2024-01-16

Publications

Saborido-Alconchel A, Serna-Gallego A, Trujillo-Rodriguez M, Munoz-Muela E, Alvarez-Rios AI, Lozano C, Llaves-Flores S, Espinosa N, Roca-Oporto C, Herrero M, Sotomayor C, Gutierrez-Valencia A, Lopez-Cortes LF. Long-term effects on immunological, inflammatory markers, and HIV-1 reservoir after switching to a two-drug versus maintaining a three-drug regimen based on integrase inhibitors. Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BIC	Unknown	50 mg	Oral
Comparator	DTG	Unknown	50 mg	Oral
Subject	FTC	Unknown	200 mg	Oral
Comparator	Lamivudine	Other / unclassified	300 mg	Oral
Subject	TAF	Unknown	25 mg	Oral

A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

Summary

Timeline

Publications

Drugs

Indications