A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 8, 2017

Primary Completion Date

April 23, 2019

Study Completion Date

April 23, 2019

Conditions
HIV Infections
Interventions
DRUG

ELV/COBI/FTC/TAF

Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.

DRUG

DTG/3TC/ABC + ELV/COBI/FTC/TAF

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks

Trial Locations (6)

Unknown

Hospital Puerta de Hierro, Majadahonda

Hospital Fundación Jimenez Díaz, Madrid

Hospital Ramón y Cajal, Madrid

Hospital Univ. Infanta Leonor, Madrid

Hospital Univ. La Princesa, Madrid

Hospital Universitario La Paz, Madrid

All Listed Sponsors
lead

Fundacion SEIMC-GESIDA

OTHER

NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study | Biotech Hunter | Biotech Hunter