Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
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|ClinicalTrials.gov Identifier: NCT04079452|
Recruitment Status : Completed
First Posted : September 6, 2019
Results First Posted : April 28, 2022
Last Update Posted : April 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Doravirine Drug: Descovy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals|
|Actual Study Start Date :||February 18, 2020|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||August 31, 2020|
Experimental: Doravirine + Descovy® TAF/FTC
Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) coformulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 4 weeks
Doravirine 100 mg tablet
Other Name: MK-1439
Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Other Name: TAF/FTC
- Total Doravirine Concentrations in Cerebrospinal Fluid [ Time Frame: 4 Weeks ]Total Doravirine concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with Doravirine+FTC/TAF
- Total Doravirine Concentrations in Blood Plasma [ Time Frame: 4 Weeks ]Total Doravirine concentrations in blood plasma
- Total Doravirine Concentration CSF/Plasma Ratio [ Time Frame: 4 Weeks ]total Doravirine CSF/plasma ratio
- HIV-1 RNA in Cerebrospinal Fluid [ Time Frame: 4 Weeks ]Number of patients with HIV-1 RNA cerebrospinal fluid <40 copies/ml
- HIV-1 RNA in Blood Plasma [ Time Frame: 4 Weeks ]Number of patients with HIV-1 RNA in blood plasma <40 copies/ml
- Unbound Doravirine Concentrations in CSF [ Time Frame: 4 Weeks ]Unbound Doravirine concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with Doravirine+FTC/TAF
- Doravirine Concentrations in Blood Plasma [ Time Frame: 4 Weeks ]Unbound Doravirine concentrations in blood plasma
- Unbound Doravirine Concentration CSF/Plasma Ratio [ Time Frame: 4 Weeks ]Unbound Doravirine CSF/plasma ratio
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079452
|Hospital Universitari de Bellvitge|
|L'Hospitalet De Llobregat, Barcelona, Spain, 08907|
|Principal Investigator:||Daniel Podzamczer, PhD Chief||Hospital Universitari de Bellvitge|
Documents provided by Daniel Podzamczer, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia:
|Responsible Party:||Daniel Podzamczer, PhD: chief of the HIV and STD Unit (Infectious Disease Service), Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia|
|Other Study ID Numbers:||
2018-003915-24 ( EudraCT Number )
|First Posted:||September 6, 2019 Key Record Dates|
|Results First Posted:||April 28, 2022|
|Last Update Posted:||April 28, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Emtricitabine tenofovir alafenamide
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action