Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV)
NCT03160105 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186
Last updated 2019-08-29
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.
Conditions
- HIV-1-infection
- Antiretroviral Therapy
- Maintenance Therapy
Interventions
- 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
Sponsors & Collaborators
-
Calmy Alexandra
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-19
- Primary Completion
- 2018-04-18
- Completion
- 2019-05-20
Countries
- Switzerland
Study Locations
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