Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
BIC-PHI
1 other identifier
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 19, 2021
July 1, 2021
1.9 years
July 20, 2020
July 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Portion of patients with a VL (viral load)< 50 Copies at week 48
Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL\< 50 copies at 48 week in the intention to treat population determined by PCR
48 weeks
Secondary Outcomes (10)
Viral Load at 4,8,12,24 y 48 weeks
weeks 4,8,12,24,48
Portion of patients with > 900 cells CD4+
weeks 24 and 48
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
week 48
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
week 48
AE (adverse event) leading to discontinuation rate
week 48
- +5 more secondary outcomes
Study Arms (1)
Biktarvy
EXPERIMENTALPatients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
Interventions
Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including: * complete physical examination * register concomitant medication * blood test * concomitant medications * assessment od adverse events * assessement of compliance * PSQI and CESTA questionnaire (week 4 and 48) * Recommendation in contraception methods * Stool sample and pregnancy test urine (week 0 and 48) The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anna Crucetalead
Study Sites (1)
Hospital Clinic
Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project Manager
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 23, 2020
Study Start
December 4, 2020
Primary Completion
November 1, 2022
Study Completion
June 1, 2023
Last Updated
July 19, 2021
Record last verified: 2021-07