Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Cruceta
• Treatments: Emtricitabine; Tenofovir

Criteria

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).