Doravirine concentrations and antiviral activity in Cerebrospinal fluid in HIV-1 Infected individuals

Doravirine concentrations and antiviral activity in Cerebrospinal fluid in HIV-1 Infected individuals - DORACeNeS

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003915-24-ES

Enrollment

Registered

2019-04-12

Start date

2019-07-29

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infected individuals

Interventions

Product Name: Doravirine Product Code: MK-1439 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DORAVIRINE CAS Number: 13382

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Asymptomatic, HIV-1 infected individuals = 18 years of age 2. 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. 3. Plasma HIV-1 RNA at screening =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Severe hepatic impairment (Child-Pugh Class C) 2. Ongoing malignancy 3. Active opportunistic infection 4. 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. 5. Any verified Grade 4 laboratory abnormality 6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN 7. Adequate renal function: Estimated glomerular filtration rate = 50 mL/min 8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding. 9. Current treatment with antiaggregant or anticoagulant therapy. 10. History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ; Secondary Objective: -To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ; Primary end point(s): -To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ;Timepoint(s) of evaluation of this end point: 4 months	—

Measure

Time frame

Main Objective: - To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ; Secondary Objective: -To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ; Primary end point(s): -To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. ;Timepoint(s) of evaluation of this end point: 4 months

—

Secondary

Measure	Time frame
Secondary end point(s): not aplicable;Timepoint(s) of evaluation of this end point: not aplicable	—

Countries

Spain

Contacts

Public ContactDaniel Podzamczer

Hospital Universitari de Bellvitge

dpodzamczer@bellvitgehospital.cat+34932607667

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026