HIV Primary InfectionPhase 2BIC-PHINCT04483674
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
A Phase 2 study testing 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide in people with HIV Primary Infection, run by Anna Cruceta at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Primary Infection
- What is being tested?
- 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2020to Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Jose María Miró, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 08036
Jose M Miró, MD
Juan Ambrosioni, MD
About this study
The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection
Read the 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.
- Conditions
- HIV Primary Infection
- Being tested
- 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
- Keywords
- Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamideDrug
Also called Biktarvy
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
| Study group | Role | What they receive |
|---|---|---|
| Biktarvy | Experimental | Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks Receives: Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (10)
Viral Load at 4,8,12,24 y 48 weeks
Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
Measured: weeks 4,8,12,24,48
Portion of patients with > 900 cells CD4+
Proportion of patients with >900 cells CD4+
Measured: weeks 24 and 48
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
Measured: 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
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
Measured: week 48
AE (adverse event) leading to discontinuation rate
AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
Measured: week 48
CD4, CD4/CD8 ratio
CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
Measured: weeks 4,8,12,24,48
AE rate
AE rate (overall and AE leading to discontinuation)
Measured: week 48
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).
Measured: week 48
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
Measured: day 0, week 4 and 48
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Measured: weeks 0,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start4 Dec 2020
- Primary completionNov 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Primary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483674
- Sponsor's protocol ID
- 2020-000601-89
- Acronym
- BIC-PHI
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2020
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
- ClinicalTrials.gov ID
- NCT04483674
- Acronym / sponsor ID
- BIC-PHI / 2020-000601-89
- Conditions
- HIV Primary Infection
- Keywords
- Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biktarvy | Experimental | Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamidePatients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamideAlso: BiktarvyPatients 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 | Drug | Biktarvy |
Primary outcome
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
10 secondary outcomes
Viral Load at 4,8,12,24 y 48 weeks
Time frame: weeks 4,8,12,24,48
Portion of patients with > 900 cells CD4+
Time frame: weeks 24 and 48
Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
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
Time frame: week 48
AE (adverse event) leading to discontinuation rate
Time frame: week 48
CD4, CD4/CD8 ratio
Time frame: weeks 4,8,12,24,48
AE rate
Time frame: week 48
Number of required regimen changes
Time frame: week 48
Quality of life and satisfaction: questionnaire
Time frame: day 0, week 4 and 48
Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
Time frame: weeks 0,48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose María Miró, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide in people with HIV Primary Infection, run by Anna Cruceta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Cruceta, MD (9322754000 ext. 4380, acruceta@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portion of patients with a VL (viral load)< 50 Copies at week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.