Journal of Pharmacovigilance

Abstract

Effect of Tenofovir/Emtricitabine/Efavirenz with and without Chloroquine in Patients with HIV/AIDS C3: Double Blinded Randomized Clinical Trial

Banda-Lara Marco Isaac, Martínez-García María del Carmen, Vázquez-Rosales José Guillermo, Rendón-Macías Mario Enrique, Flores-Hernández Sergio, Rivera-Benítez César, Santos-González Margarito and Carrillo-Avalos Blanca

Background: The use of antiretroviral therapy (ART) reduces both mortality and morbidity of patients with HIV/ AIDS. The effects of chloroquine against HIV replication are widely known.

Objective: To demonstrate that beginning HIV treatment with ART (tenofovir/emtricitabine/efavirenz) + chloroquine increases by at least 20% the proportion of patients with viral load (VL) <50 copies/mL and >200 CD4+/mcL compared to patients receiving only ART at six months follow up.

Method: A randomized double-blind clinical trial was performed in 95 patients at the Infectious Diseases Department of the Hospital General de Mexico diagnosed with HIV/AIDS classification C3 before their first ART: 48 patients in the ART + placebo group and 47 in the ART + chloroquine group.

Results: A difference of 37% at six months of treatment in advantage of the group of ART + chloroquine (p<0.001), and seven times greater chance of improvement using chloroquine in the first six months of treatment. Chloroquine decreased the frequency of IRIS in 20%, compared with the group that initiated ART only at six months follow-up with statistical difference (p=0.029).

Conclusion: Chloroquine can improve the immune response and decrease the frequency of inflammatory syndrome by immune reconstitution at six months if added to the initial ART with tenofovir/emtricitabine/efavirenz.