Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).

Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”). - BIGER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002310-12-ES

Enrollment

Registered

2018-07-17

Start date

2018-11-19

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

HIV-1 infected male and female adults not previously exposed to ART.

Interventions

Product Name: Bictegravir, emtricitabine, tenofovir alafenamide Product Code: J05AR20 Pharmaceutical Form: Tablet INN or Proposed INN: BICTEGRAVIR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV-1 infected male and female = 18 years of age. 2. Not previously exposed to ART 3. Plasma viral load (HIV-1 RNA) at screening >1000 copies/mL 4. Signed and dated written informed consent prior to inclusion. 5. 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 23 F.1.3 Elderly (>=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 the study ARV 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: -To evaluate HIV viral kinetics in seminal plasma and rectal fluid, and cervicovaginal fluid in HIV-1 infected ART naïve male and female individuals, respectively, initiating Bictegravir/FTC/TAF. - To determine Bictegravir concentrations in fluid and tissue from the male and female genital tract (seminal plasma and cervicovaginal fluid) and rectal compartment (rectal tissue and rectal fluid) in HIV-1 infected male and female individuals receiving ART with Bictegravir/FTC/TAF. ;Secondary Objective: there are no secondary objectives; Primary end point(s): -HIV-1 RNA decay in seminal plasma, rectal fluid and cervicovaginal fluid from baseline and up to 6 months after initiation of Bictegravir/FTC/TAF. - Concentration of Bictegravir in seminal plasma, cervicovaginal fluid, rectal tissue and rectal fluid at weeks 2 and 4 after initiation a first ART regimen with Bictegravir/FTC/TAF. ;Timepoint(s) of evaluation of this end point: 10 months	—

Measure

Time frame

Main Objective: -To evaluate HIV viral kinetics in seminal plasma and rectal fluid, and cervicovaginal fluid in HIV-1 infected ART naïve male and female individuals, respectively, initiating Bictegravir/FTC/TAF. - To determine Bictegravir concentrations in fluid and tissue from the male and female genital tract (seminal plasma and cervicovaginal fluid) and rectal compartment (rectal tissue and rectal fluid) in HIV-1 infected male and female individuals receiving ART with Bictegravir/FTC/TAF. ;Secondary Objective: there are no secondary objectives; Primary end point(s): -HIV-1 RNA decay in seminal plasma, rectal fluid and cervicovaginal fluid from baseline and up to 6 months after initiation of Bictegravir/FTC/TAF. - Concentration of Bictegravir in seminal plasma, cervicovaginal fluid, rectal tissue and rectal fluid at weeks 2 and 4 after initiation a first ART regimen with Bictegravir/FTC/TAF. ;Timepoint(s) of evaluation of this end point: 10 months

—

Secondary

Measure	Time frame
Secondary end point(s): -HIV-1 RNA decay in blood plasma from baseline and up to 6 months after initiation of Bictegravir/FTC/TAF. - Concentration of Bictegravir in blood plasma at weeks 2 and 4 after initiation a first ART regimen with Bictegravir/FTC/TAF. ;Timepoint(s) of evaluation of this end point: 10 MONTHS	—

Countries

Spain

Contacts

Public ContactUnidad de VIH

Hospital Universitari de Bellvitge

lacerete@bellvitgehospital.cat00349333590112876

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026