Status:
UNKNOWN
Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)
Lead Sponsor:
University of Sussex
Collaborating Sponsors:
Brighton and Sussex University Hospitals NHS Trust
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Improvements in health care and antiretroviral treatments have made it possible to turn HIV into a chronic disease leading to longer life expectancies and better quality of life among patients. Dual-d...
Detailed Description
The investigators propose a three-phase comparative study with a control population (i.e., people living with HIV on other dual therapy regimens and triple ART) and the target population (i.e., people...
Eligibility Criteria
Inclusion
- Adults (aged 18 years old or older)
- Able to consent
- Receive HIV care at the HIV Department of the Brighton and Sussex University Hospital (Lawson Unit/Elton John Centre)
- All genders, sexual orientations, and socio-economic groups are eligible for participation
- On one of the following therapies
- Control population
- Juluca (DTG/rilpivirine\[RPV\])
- Boosted darunavir plus lamivudine (DRV/r or DRV/c + 3TC)
- Boosted darunavir plus raltegravir (DRV/r or DRV/c + RAL)
- A triple regimen (2 nucleos(t)ide reverse transcriptase inhibitors \[NRTIs\] + 1 InSTI; 2 NRTIs + 1 non-nucleoside reverse transcriptase inhibitor \[NNRTI\]; 2 NRTIs + boosted protease inhibitor \[PI/b\])
- Target population
- DTG/3TC
Exclusion
- Patients taking off-label drug combinations due to complex HIV resistance patterns.
- ART naïve or individuals declining ART will be excluded.
- Patients without access to the technology to participate in the online study will be given the option to participate in person (following COVID-19 guidance), and if this is not possible they will be excluded.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04901728
Start Date
July 1 2021
End Date
July 30 2022
Last Update
May 25 2022
Active Locations (1)
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1
Royal Sussex County Hospital, Brighton, UK
Brighton, United Kingdom, BN2 5BE