Status:
UNKNOWN
Patient-Reported Outcomes HIV BItherapy
Lead Sponsor:
University Paris 7 - Denis Diderot
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV/AIDS and Infections
Patient Preference
Eligibility:
All Genders
18+ years
Brief Summary
HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order t...
Eligibility Criteria
Inclusion
- Patients infected by HIV-1
- Patients who are prescribed the Dovato regimen by their clinicians in routine care
- Patients previously under the cART regimen with three or four antiretrovirals
- HIV-RNA \<=50 copies/mL for at least 3 months
- 18 years old and more
- Ability to understand and respond to questionnaires
Exclusion
- Pregnant or breastfeeding women
- Known hypersensitivity to dolutegravir and lamivudine, their metabolites or formulation excipient
- Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to inclusion
- Any other clinical condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable to comply with protocol requirements.
- Active CDC Category C disease
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents 30 days before inclusion
- Patient co-infected with HBV
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04788784
Start Date
April 12 2021
End Date
August 31 2022
Last Update
April 30 2021
Active Locations (3)
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1
Hôpital de Bicêtre
Le Kremlin-Bicêtre, France, 94275
2
Centre hospitalier de Cornouaille
Quimper, France, 29107
3
Centre Hospitalier de Saint-Denis - Hôpital Delafontaine
Saint-Denis, France, 93200