Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals

Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals - BICS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000302-39-ES

Enrollment

Registered

2018-04-09

Start date

2018-06-18

Completion date

Unknown

Last updated

2018-11-26

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

Conditions

HIV-1 infected individuals

Interventions

Trade Name: Bictegravir/FTC/TAF Product Name: emtricitabine, tenofovir alafenamide and bictegravir Pharmaceutical Form: Tablet INN or Proposed INN: BICTEGRAVIR Current Sponsor code: BIC Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Asymptomatic, HIV-1 infected individuals = 18 years of age - Be on a stable ART consisting of TDF/FTC or ABC/3TC plus 1NNRTI, 1 boosted PI or 1 integrase inhibitor, continously or =3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC/BIC for at least three consecutive months will be eligible. - Plasma HIV-1 RNA at screening =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS. -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.;Secondary Objective: - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS. -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.;Primary end point(s): - To determine total and unbound Bictegravir concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with TAF/FTC/Bictegravir. -Total Bictegravir concentrations in blood plasma. - Bictegravir CSF/plasma ratio. -HIV-1 RNA in cerebrospinal fluid. -HIV-1 RNA in blood plasma.;Timepoint(s) of evaluation of this end point: 4 months	—

Measure

Time frame

Main Objective: - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS. -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.;Secondary Objective: - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS. -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.;Primary end point(s): - To determine total and unbound Bictegravir concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with TAF/FTC/Bictegravir. -Total Bictegravir concentrations in blood plasma. - Bictegravir CSF/plasma ratio. -HIV-1 RNA in cerebrospinal fluid. -HIV-1 RNA in blood plasma.;Timepoint(s) of evaluation of this end point: 4 months

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Spain

Contacts

Public ContactAlbert Tuldrà

Fundadció Lluita contra la SIDA

atuldra@flsida.org0034934657897

Outcome results

None listed

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