Status:
UNKNOWN
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Lead Sponsor:
Anna Cruceta
Conditions:
HIV Primary Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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
Detailed 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 table...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04483674
Start Date
December 4 2020
End Date
June 1 2023
Last Update
July 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinic
Barcelona, Spain, 08036