NCT02503462

Brief Summary

The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

July 9, 2015

Last Update Submit

February 1, 2017

Conditions

AIDS-related Dementia Complex

Keywords

HIVdarunavirritonavircobicistatCSFpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Cerebrospinal fluid/plasma concentrations (ng/ml) of darunavir/ritonavir versus darunavir/cobicistat

    darunavir concentrations (ng/ml) in the cerebrospinal fluid when coadministered with ritonavir versus cobicistat relative to the corresponding concentrations of darunavir in the plasma

    1 month

Secondary Outcomes (2)

  • Cerebrospinal fluid concentrations (ng/ml) of darunavir/ritonavir versus darunavir/cobicistat relative to the concentration of darunavir (ng/ml) inhibiting 50% (IC50) or 90% (IC90) of the viral replication

    1 month

  • Proportion of responders (HIV RNA < 50 copies/ml in CSF) for darunavir/ritonavir versus darunavir/cobicistat

    1 month

Study Arms (1)

darunavir/ritonavir vs cobicistat

EXPERIMENTAL

All HIV infected patients will be treated with a darunavir/ritonavir (800/100 mg) once daily containing regimen. Darunavir/ritonavir concentrations will be measured simultaneously in CSF and plasma after 1 month of treatment. The treatment will be switched to darunavir/cobicistat (800/150 mg) once daily and darunavir/cobicistat levels will be measured in CSF and plasma after 1 month of treatment.

Drug: DarunavirDrug: ritonavirDrug: cobicistat

Interventions

DarunavirDRUG

darunavir 800 mg once daily will be first given together with ritonavir 100 mg once daily for one month (period 1) and then darunavir 800 mg once daily will be given together with cobicistat 150 mg once daily for one month (period 2). Afterwards, all patients will be switched back to darunavir/ritonavir (800/100 mg once daily).

Also known as: Prezista
darunavir/ritonavir vs cobicistat
ritonavirDRUG

ritonavir 100 mg once daily will be used to boost darunavir 800 mg once daily (period 1).

Also known as: Norvir
darunavir/ritonavir vs cobicistat
cobicistatDRUG

cobicistat 150 mg once daily will be used to boost darunavir 800 mg once daily (period 2).

Also known as: Tybost
darunavir/ritonavir vs cobicistat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented HIV infection
  • presence of HIV associated neurocognitive disorders requiring a lumbar puncture for clinical reasons
  • treatment or qualifying to be treated with a HIV therapy including darunavir/r (800/100 mg once daily)
  • ability to comply with the study requirements
  • informed consent

You may not qualify if:

  • conditions which disrupt the blood-brain barrier and thereby impact the entry of drugs in the brain (meningitis, meningoencephalitis, multiple sclerosis, progressive multifocal leucoencephalopathy)
  • co-medications inhibiting/inducing P-glycoprotein and BCRP
  • co-medications inhibiting/inducing cytochrome P450 isoenzyme 3A4 (CYP3A4)
  • non adherence to Treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Infectious Diseases, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Bartels H, Decosterd L, Battegay M, Marzolini C. Darunavir concentrations in CSF of HIV-infected individuals when boosted with cobicistat versus ritonavir. J Antimicrob Chemother. 2017 Sep 1;72(9):2574-2577. doi: 10.1093/jac/dkx165.

    PMID: 28575323DERIVED

MeSH Terms

Conditions

AIDS Dementia Complex

Interventions

DarunavirRitonavirCobicistat

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Study Officials

  • Manuel Battegay

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 21, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

CH(1)