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

Phase 1

• Conditions: HIV-1 infected individuals; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-000302-39-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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 <40 copies/mL for at least 6 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS.<br>-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.<br>-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.<br>-Total Bictegravir concentrations in blood plasma.<br>- Bictegravir CSF/plasma ratio.<br>-HIV-1 RNA in cerebrospinal fluid.<br>-HIV-1 RNA in blood plasma.;Timepoint(s) of evaluation of this end point: 4 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable