HIV InfectionsPhase 4BICOLDERNCT04222283
Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
A Phase 4 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 8 sites in France.
Trial summary
Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesFrance
- Study dates
- 17 Aug 2020to 30 Jun 2022
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- HIV-1-infected patient
- Age > 65 years old
- Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening.
- Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
- No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
- If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed.
- Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program)
- Informed consent form signed by patient and investigator
Who cannot join
- HIV-2 infection
- Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
- Hemoglobin < 10g/dL
- Platelets < 100 000/mm3
- Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
- Severe hepatic insufficiency (Child Pugh Class C)
Show all 10Show fewer
- Creatininemia clairance < 30 mL/min (MDRD)
- History or presence of allergy to the trial drugs or their components
- Patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase
- Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites, 6 recruiting
- Recruiting
Hopital Sainte Marguerite
Marseille, 13009
ISABELLE POZOT MARTIN, 0491746163 ext. 334, isabelle.poizot@mail.ap-hm.fr
Isabelle POIZOT-MARTIN, MD,PHD
- Recruiting
Hopital Hotel Dieu
Nantes, 44093
CLOTILDE ALLAVENA, 40083110 ext. 332, clotilde.allavena@chu-nantes.fr
CLOTILDE ALLAVENA
- Recruiting
Hopital L'Archet
Nice
Alissa NAQVI
naqvi.a@chu-nice.fr
- Recruiting
Hôpital Hotel Dieu
Paris, 75004
Laurence WEISS
laurence.weiss@aphp.fr
- Recruiting
Bichat Hospital
Paris, 75018
Valentina ISERNIA, MD, 40257057 ext. 331, valentina.isernia@aphp.fr
BAO PHUNG, MD, 40257057 ext. 331, bao.phung@aphp.fr
- Active, not recruiting
CH de Saint Nazaire
Saint-Nazaire
- Recruiting
Hopital Gustave Dron
Tourcoing, 59208
FAIZA AJANA, 0320694617 ext. 333, fajana@ch-tourcoing.fr
FAIZA AJANA
- Active, not recruiting
Hopital Bretonneau
Tours
About this study
Official title: Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.
Read the detailed description
HIV-1-infected patients over 65 years old at risk of polymedication HIV-1-infected adults aged ≥ 65 years who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC
- Conditions
- HIV Infections
- Being tested
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIKTARVY 50Mg-200Mg-25Mg TabletDrug
At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).
| Study group | Role | What they receive |
|---|---|---|
| open label, multicentric, non randomized | Experimental | one arm study to evaluate the safety and efficacy of switching from ritonavir- or cobicistat- booster containing regimens to a fixed-dose combination (FDC) of tenofovir alafenamide (TAF), emtricitabine (FTC) and bictegravir (BIC) in over 65 years old HIV-1-infected patients with virological suppression. Polymedications and drug-drug interactions will be analysed. Receives: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
The primary outcome is the proportion of patients with virological failure at Week 24.
Measured: Week 24
Secondary outcomes (16)
Charlson and Fried Score
- Assessment of co morbidities and frailty
Measured: Day 1, Week 24 and Week 48
DAD Score
- Assessment of cardio vascular risk
Measured: Day 1,Week 24 and Week 48
polymedication
- Assessment of polymedication and potential drug-drug interactions
Measured: Baseline, Week 24 and Week 48
drug interactions
- Change of drug-drug interactions
Measured: Baseline To Week 48
• adverses events
Rate of participants withdrawn from the study for grade 3 or 4 adverse event
Measured: Baseline To Week 48
therapeutic success
- Rate of therapeutic success
Measured: Week 24 and Week 48
Viral load detectable
- Rate of participants with detectable signal in case viral load is less than 20 c/ml threshold (Cobas/TaqmanHIV-1 Roche Diagnostics) at W24 and W48
Measured: From Baseline to Week 48
Blip detectable
- Rate of participants with a blip
Measured: Baseline to Week 48
mutation
- Emergence of resistance mutations at time of virological failure
Measured: Day 1 to Week 48
immunology parameters
- Change of CD4 and CD8 cell count from BSL,
Measured: Baseline, to Week 24 and Week 48
lipid parameters
- Evolution of lipid parameters
Measured: Baseline, Week 24, Week 48
Renal parameters
Renal glomerular filtration, creatinine clearance
Measured: Baseline,Week 4,Week 12,Week 24 and Week 48 ;
pharmacology
- Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
Measured: Baseline, Week 12, Week 24, Week 48
Addherence
- Adherence to treatment: self-administered questionnaire
Measured: Baseline, Week 24 and Week 48
Tolerance
- Tolerance to treatment: questionnaire
Measured: Week 4, Week 24 and Week 48
Renal parameters (Urine)
urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein
Measured: Baseline, Week 24, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start17 Aug 2020
- Primary completion20 Dec 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre and Marie Curie University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222283
- Sponsor's protocol ID
- IMEA 057
- Acronym
- BICOLDER
- Status last verified
- Jun 2022
- First submitted
- 5 Dec 2019
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
- ClinicalTrials.gov ID
- NCT04222283
- Acronym / sponsor ID
- BICOLDER / IMEA 057
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- Pierre and Marie Curie University
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Jan 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.
Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.
Detailed description
HIV-1-infected patients over 65 years old at risk of polymedication HIV-1-infected adults aged ≥ 65 years who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label, multicentric, non randomized | Experimental | Drug: BIKTARVY 50Mg-200Mg-25Mg Tabletone arm study to evaluate the safety and efficacy of switching from ritonavir- or cobicistat- booster containing regimens to a fixed-dose combination (FDC) of tenofovir alafenamide (TAF), emtricitabine (FTC) and bictegravir (BIC) in over 65 years old HIV-1-infected patients with virological suppression. Polymedications and drug-drug interactions will be analysed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- HIV-1-infected patient
- Age > 65 years old
- Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening.
- Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
- No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
Key exclusion criteria (10 listed)
- HIV-2 infection
- Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
- Hemoglobin < 10g/dL
- Platelets < 100 000/mm3
- Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
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 |
|---|---|---|
| BIKTARVY 50Mg-200Mg-25Mg TabletAt BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY). | Drug | open label, multicentric, non randomized |
Primary outcome
Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
Time frame: Week 24
The primary outcome is the proportion of patients with virological failure at Week 24.
16 secondary outcomes
Charlson and Fried Score
Time frame: Day 1, Week 24 and Week 48
DAD Score
Time frame: Day 1,Week 24 and Week 48
polymedication
Time frame: Baseline, Week 24 and Week 48
drug interactions
Time frame: Baseline To Week 48
• adverses events
Time frame: Baseline To Week 48
therapeutic success
Time frame: Week 24 and Week 48
Viral load detectable
Time frame: From Baseline to Week 48
Blip detectable
Time frame: Baseline to Week 48
mutation
Time frame: Day 1 to Week 48
immunology parameters
Time frame: Baseline, to Week 24 and Week 48
lipid parameters
Time frame: Baseline, Week 24, Week 48
Renal parameters
Time frame: Baseline,Week 4,Week 12,Week 24 and Week 48 ;
pharmacology
Time frame: Baseline, Week 12, Week 24, Week 48
Addherence
Time frame: Baseline, Week 24 and Week 48
Tolerance
Time frame: Week 4, Week 24 and Week 48
Renal parameters (Urine)
Time frame: Baseline, Week 24, Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 8 sites in France.
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 8 inclusion and 10 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 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Aïda BENALYCHERIF (40256365 ext. 331, aida.benalycherif@fondation-imea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart (time frame: Week 24). 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 10 Jun 2022.