Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection (BIC-PHI)

July 16, 2021 updated by: Anna Cruceta
The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic
        • Principal Investigator:
          • Juan Ambrosioni, MD
        • Principal Investigator:
          • Jose M Miró, MD
        • Sub-Investigator:
          • Josep Mallolas, MD
        • Sub-Investigator:
          • Sonsoles Sanchez
        • Sub-Investigator:
          • Montserrat Plana
        • Sub-Investigator:
          • Cristina Rovira
        • Sub-Investigator:
          • Carmen Hurtado
        • Sub-Investigator:
          • José Alcamí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biktarvy
Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide

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

Other Names:
  • Biktarvy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Portion of patients with a VL (viral load)< 50 Copies at week 48
Time Frame: 48 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Viral Load at 4,8,12,24 y 48 weeks
Time Frame: weeks 4,8,12,24,48
Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
weeks 4,8,12,24,48
Portion of patients with > 900 cells CD4+
Time Frame: weeks 24 and 48
Proportion of patients with >900 cells CD4+
weeks 24 and 48
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
Time Frame: week 48
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit 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
Time Frame: 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 in comparison with other InSTI-, based ART regimens
week 48
AE (adverse event) leading to discontinuation rate
Time Frame: week 48
AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
week 48
CD4, CD4/CD8 ratio
Time Frame: weeks 4,8,12,24,48
CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
weeks 4,8,12,24,48
AE rate
Time Frame: week 48
AE rate (overall and AE leading to discontinuation)
week 48
Number of required regimen changes
Time Frame: week 48
Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).
week 48
Quality of life and satisfaction: questionnaire
Time Frame: day 0, week 4 and 48
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
day 0, week 4 and 48
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Time Frame: weeks 0,48
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
weeks 0,48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anna Cruceta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-000601-89

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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