NCT04076423

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

A Phase IV, Multicenter, Open and Randomized Study to Assess the Impact of the Change From Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With Type 1 HIV Infection. InSTINCT Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dual Therapy	DTG + 3TC
DRUG	Triple therapy	BIC / FTC / TAF

Timeline

• Start date: 2019-10-10
• Primary completion: 2023-06-15
• Completion: 2024-01-16
• First posted: 2019-09-03
• Last updated: 2024-10-01

Locations

18 sites across 1 country: Spain