Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection (BIC-PHI)
Primary Purpose
HIV Primary Infection
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
Sponsored by
About this trial
This is an interventional treatment trial for HIV Primary Infection focused on measuring Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy
Eligibility 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).
Sites / Locations
- Hospital ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biktarvy
Arm Description
Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Viral Load at 4,8,12,24 y 48 weeks
Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
Portion of patients with > 900 cells CD4+
Proportion of patients with >900 cells CD4+
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens
AE (adverse event) leading to discontinuation rate
AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
CD4, CD4/CD8 ratio
CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
AE rate
AE rate (overall and AE leading to discontinuation)
Number of required regimen changes
Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).
Quality of life and satisfaction: questionnaire
Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483674
Brief Title
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Acronym
BIC-PHI
Official Title
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Cruceta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Primary Infection
Keywords
Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biktarvy
Arm Type
Experimental
Arm Description
Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
Other Intervention Name(s)
Biktarvy
Intervention Description
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
Primary Outcome Measure Information:
Title
Portion of patients with a VL (viral load)< 50 Copies at week 48
Description
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
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Viral Load at 4,8,12,24 y 48 weeks
Description
Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
Time Frame
weeks 4,8,12,24,48
Title
Portion of patients with > 900 cells CD4+
Description
Proportion of patients with >900 cells CD4+
Time Frame
weeks 24 and 48
Title
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
Description
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation
Time Frame
week 48
Title
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
Description
Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens
Time Frame
week 48
Title
AE (adverse event) leading to discontinuation rate
Description
AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
Time Frame
week 48
Title
CD4, CD4/CD8 ratio
Description
CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
Time Frame
weeks 4,8,12,24,48
Title
AE rate
Description
AE rate (overall and AE leading to discontinuation)
Time Frame
week 48
Title
Number of required regimen changes
Description
Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).
Time Frame
week 48
Title
Quality of life and satisfaction: questionnaire
Description
Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period
Time Frame
day 0, week 4 and 48
Title
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Description
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Time Frame
weeks 0,48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Cruceta, MD
Phone
9322754000
Ext
4380
Email
acruceta@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Jose María Miró, MD
Email
jmmiro@clinic.cat
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose M Miró, MD
First Name & Middle Initial & Last Name & Degree
Juan Ambrosioni, MD
First Name & Middle Initial & Last Name & Degree
Josep Mallolas, MD
First Name & Middle Initial & Last Name & Degree
Sonsoles Sanchez
First Name & Middle Initial & Last Name & Degree
Montserrat Plana
First Name & Middle Initial & Last Name & Degree
Cristina Rovira
First Name & Middle Initial & Last Name & Degree
Carmen Hurtado
First Name & Middle Initial & Last Name & Degree
José Alcamí
12. IPD Sharing Statement
Learn more about this trial
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
We'll reach out to this number within 24 hrs