Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection (BIC-PHI)

Anna Cruceta

Status and phase

Unknown

Phase 2

Conditions

HIV Primary Infection

Treatments

Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04483674

2020-000601-89

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

Full description

After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients aged 18-65 years
ART naïve
HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.

Exclusion criteria

Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
AST >5 times UNL
Creatinine Clearance <30 mL/min/1.73m2
Any end-stage organ disease
Acute or chronic HCV co-infection
Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).