NCT03160105

Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV)

Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Calmy Alexandra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.

Detailed description

This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization to switching to DTG-based maintenance dual therapy in association with FTC or continuation of cART, and to patient-centered monitoring or continuation of standard monitoring. Patients will be followed during 48 weeks.

Conditions

• HIV-1-infection
• Antiretroviral Therapy
• Maintenance Therapy

Interventions

Type	Name	Description
DRUG	Switch to DTG + FTC	Switch from standard cART to DTG + FTC dual maintenance therapy.
OTHER	Patient-centered monitoring	Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36

Timeline

• Start date: 2017-05-19
• Primary completion: 2018-04-18
• Completion: 2019-05-20
• First posted: 2017-05-19
• Last updated: 2019-08-29

Locations

7 sites across 1 country: Switzerland