Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil
NCT04903847 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2021-05-27
Summary
Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
Conditions
- Hiv
- HIV Infections
- HIV Lipodystrophy
- Osteoporosis
- Renal Insufficiency
- Weight Gain
- Obesity
Interventions
- DRUG
-
Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
Two-drug therapy
- DRUG
-
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Three-drug therapy
Sponsors & Collaborators
-
Thomas Benfield
lead OTHER
Principal Investigators
-
Thomas Benfield, MD · Center of Research and Disruption of Infectious Diseases
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-02
- Primary Completion
- 2023-02-02
- Completion
- 2023-02-02
Countries
- Denmark
Study Locations
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