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DoRIS: Dolutegravir PK with Escalating Rifampicin
NCT04166474Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2021
- Primary completion
- Feb 2024
- Countries
- 2
- Modality
- Small Molecules
- Drugs
- dolutegravir
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 4, open-label, single-arm trial of dolutegravir in human immunodeficiency virus infection (HIV). Primary endpoint: Minimum Plasma Concentration. Started Nov 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dolutegravir PK
Sequential dosing of Dolutegravir with escalating Rifampicin doses followed by Dolutegravir alone.
03
Who it enrols
HIV-negative adults with tuberculosis on standard rifampicin-based therapy, weighing at least 50 kg.
04
Endpoints
Primary
Minimum Plasma Concentration
Secondary
Area Under the Curve
Maximum Plasma Concentration
Grade 3 and above Adverse Events
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