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

Last updated: July 16, 2021
Sponsor: Anna Cruceta
Overall Status: Active - Recruiting

Phase

2

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04483674
2020-000601-89
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 ofacquired-drug resistance to FCT or TDF).

Study Design

Total Participants: 66
Study Start date:
December 04, 2020
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Active - Recruiting

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