Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04079452 |
Recruitment Status :
Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : May 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV-1-infection | Drug: Doravirine Drug: Descovy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals |
Estimated Study Start Date : | June 2020 |
Estimated Primary Completion Date : | July 2020 |
Estimated Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
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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
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Drug: Doravirine
Doravirine 100 mg tablet
Other Name: MK-1439 Drug: Descovy Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Other Name: TAF/FTC |
- Doravirine concentrations in CSF [ Time Frame: 4 Weeks ]To determine total and 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 ]Total Doravirine concentrations in blood plasma
- Doravirine CSF/plasma ratio [ Time Frame: 4 Weeks ]Doravirine CSF/plasma ratio
- HIV-1 RNA in cerebrospinal fluid [ Time Frame: 4 Weeks ]HIV-1 RNA in cerebrospinal fluid
- HIV-1 RNA in blood plasma [ Time Frame: 4 Weeks ]HIV-1 RNA in blood plasma

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contact: Juan Manuel Tiraboschi, PhD | +34932607667 ext 2885 | jmtiraboschi@bellvitgehospital.cat | |
Contact: Arkaitz Imaz, PhD | +34932607667 ext 2883 | aimaz@bellvitgehospital.cat |
Spain | |
Hospital Universitari de Bellvitge | |
L'Hospitalet De Llobregat, Barcelona, Spain, 08907 | |
Contact: Camila Piatti +34933359011 ext 2876 cpiatti@bellvitgehospital.cat | |
Contact: Laura Acerete +34933359011 ext 2876 lacerete@bellvitgehospital.cat | |
Principal Investigator: Daniel Podzamczer, PhD | |
Sub-Investigator: Juan Manuel Tiraboschi, PhD | |
Sub-Investigator: Arkaitz Imaz, PhD |
Principal Investigator: | Daniel Podzamczer, PhD Chief | Hospital Universitari de Bellvitge |
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 |
ClinicalTrials.gov Identifier: | NCT04079452 |
Other Study ID Numbers: |
DORACeNeS 2018-003915-24 ( EudraCT Number ) |
First Posted: | September 6, 2019 Key Record Dates |
Last Update Posted: | May 6, 2020 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Doravirine |