Status:
COMPLETED
Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Hospital Universitari de Bellvitge
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Doravirine is a new HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) that has demonstrated a good efficacy and safety profile in clinical trials. It functions by inhibiting viral replicati...
Detailed Description
15 asymptomatic, virologically suppressed, HIV infected patients will be offered to switch their antiretroviral treatment to Doravirine+Emtricitabine/TAF. After 4 weeks of treatment all subjects will ...
Eligibility Criteria
Inclusion
- Asymptomatic, HIV-1 infected individuals ≥ 18 years of age
- Be on a stable ART continously or ≥3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC+DoravirineC for at least three consecutive months will be eligible.
- Plasma HIV-1 RNA at screening \<40 copies/mL for at least 3 months at the Screening visit.
- Signed and dated written informed consent prior to inclusion.
- Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
Exclusion
- Severe hepatic impairment (Child-Pugh Class C)
- Ongoing malignancy
- Active opportunistic infection
- Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
- Any verified Grade 4 laboratory abnormality
- ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min
- Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
- Current treatment with antiaggregant or anticoagulant therapy.
- History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04079452
Start Date
February 18 2020
End Date
August 31 2020
Last Update
April 28 2022
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907