HIV-1-infectionPhase 1NCT04950530
The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
A Phase 1 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with HIV-1-infection, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- 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
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Dec 2022to 29 Feb 2024
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent
- Cis-Male and Cis-Female healthy subjects without underlying conditions
- Cis-Male and Cis-Female subjects with recruitment stratified to include at least 6 female subjects and at least 6 subjects of black Africa origin
- Subjects must have documented negative HIV serology by ELISA and P24 antigen and not receiving anti-HIV pre-exposure prophylaxis (PreP)
- Subjects must be clinically well volunteers aged between 18 to 60 years with BMI <30 kg/m2 but >18 kg/m2
- Healthy, as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (including ECG)
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- Non-fasting blood glucose, total cholesterol and triglycerides within normal limits
- Subjects should have complete blood count (FBC) with normal differential and platelet count
- A female, may be eligible to enter and participate in the study if she:
- is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
- Complete abstinence from penile-vaginal intercourse. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant;
- Any intrauterine device with published data showing that the expected failure rate is <1% per year (not all intrauterine devices meet this criterion, see Appendix 6] for an example listing of approved intrauterine devices);
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Approved hormonal contraception (see Appendix 6] for a listing of examples of approved hormonal contraception)*;
- Any other method with published data showing that the expected failure rate is <1% per year
- Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 6) must be using an adequate method of contraception to avoid pregnancy in their partner throughout the study and for a period of at least 4 weeks after the study;
- Complete abstinence from penile-vaginal intercourse. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient;
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 4 for an example listing of approved IUDs) plus male condom;
- Sterilisation confirmed prior to the subject's entry into the study
- Approved hormonal contraception used by female partner (see protocol appendix 4 for a listing of examples of approved hormonal contraception) plus male condom;
- Any other method with published data showing that the expected failure rate is <1% per year and not containing hormones plus male condom.
- Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP (Appendix 6).
- Any contraception method must be used consistently, in accordance with the approved product label and for at least 28 days prior to the first dose of study medication and 4 weeks after discontinuing the study medication.
Who cannot join
- Subjects with a waist hip ratio > 0.97 or BMI > 30kg/m2 and BMI <18 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Diabetes mellitus, other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension. Subject with HbA1c >42 mmol/mol will be excluded.
- History or presence of allergy to the B/F/TAF
- ALT greater than or equal to 1.5 x ULN and total bilirubin greater than or equal to 1.5 x ULN excluded;
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- Pregnancy and breastfeeding women
- Alcohol consumption >10 units/week
- Clinically relevant drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- Unable to refrain from the use of prescription (e.g., dofetilide) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives prior to the baseline visit and throughout the study until the follow-up period, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise participant safety.
- This includes on-going therapy with any of the following
- Metabolically active medications
- Any lipid-lowering medication
- Hormonal agents (oestrogens or androgens)
- Glucocorticoids including inhaled steroids except for 'as necessary' use
- Beta-blockers
- Thiazide diuretics and indapamide
- Thyroid preparations
- Psychotropic agents
- Anabolic steroids
- Megestrol acetate
- Dofetilide (or pilsicainide)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea & Westminster Hospital NHS Foundation Trust
London, SW10 9NH
About this study
This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.
Read the detailed description
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of Biktarvy (B/F/TAF) compared to no B/F/TAF for 28 days in HIV seronegative healthy volunteers.
Group 1:
B/F/TAF tablet once daily for the first 28 days of the study. No treatment for the last 44 days of the study.
Group 2:
No treatment for the first 28 days of the study. B/F/TAF tablet once daily for the last 28 days of the study (day 44-72).
Research bloods, endocrine profiles, weight and urine samples will be collected at baseline, as well as day 28, 44, and 72 to enable comparative analyses.
Participants will be closely monitored whilst taking the study medications. Participants will exit the study 72 days post-randomisation, with a follow-up call 28 days after exiting.
- Conditions
- HIV-1-infection
- Being tested
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Keywords
- HIV, Insulin, Biktarvy
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIKTARVY 50Mg-200Mg-25Mg TabletDrug
Also called BIC/FTC/TAF, Bictegravir
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide taken once daily, orally
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Biktarvy - one tablet once daily, orally administered for the first 28 days of the study.
No treatment for the last 44 days of the study. Receives: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet |
| Arm 2 | Experimental | No treatment for the first 28 days of the study. Biktarvy - one tablet once daily, orally administered for the last 28 days of the study (day 44-72). Receives: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity in participants from baseline to end of study between two crossover groups
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
Measured: Baseline, day 28, 44, and 72 for both groups
Secondary outcomes (7)
Effect of Biktarvy on adipocytokines
Fasting adiponectin and leptin levels in blood.
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on fasting ghrelin
Fasting ghrelin levels in blood.
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on pituitary hormones
Pituitary hormone function tests to measure blood levels of the following:
Adrenocorticotrophic hormone (ACTH) Thyroid-stimulating hormone (TSH) Luteinising hormone (LH) Follicle-stimulating hormone (FSH) Prolactin (PRL) Melanocyte-stimulating hormone (MSH) Cortisol Insulin-like growth factors (IGFs)
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on lipid profile including lipid fractions
Lipid profile in serum samples to measure blood levels of:
Fasting cholesterol Triglycerides High-density lipoproteins (HDL) Low-density lipoproteins (LDL)
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on changes in indirect calorimetry
Indirect calorimetry by ventilated hood expires gas analysis will be used to determine energy expenditure during the course of the clamp procedures.
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on changes in food intake
Changes measured food diaries completed 3 days prior to each trial visit.
Measured: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on quality of sleep
Changes measured through the Pittsburgh Sleep Quality Index (PSQI).
Questionnaire score ranges 0-21, with higher score indicating poorer sleep quality.
Measured: Baseline, day 28, 44, and 72 for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start22 Dec 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomised to start on Biktarvy tablet once daily OR no treatment for the first 28 day dosing phase of the study then will cross over to the alternative for the second dosing phase, following a 2 week washout period (equivalent to 5+ B/F/TAF elimination half-lives).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Milinkovic, Principal investigator, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950530
- Sponsor's protocol ID
- CRF007
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2021
- Last updated
- 10 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04950530
- Acronym / sponsor ID
- CRF007
- Conditions
- HIV-1-infection
- Keywords
- HIV, Insulin, Biktarvy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 Jul 2021 (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.
This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.
Detailed description
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of Biktarvy (B/F/TAF) compared to no B/F/TAF for 28 days in HIV seronegative healthy volunteers.
Group 1:
B/F/TAF tablet once daily for the first 28 days of the study. No treatment for the last 44 days of the study.
Group 2:
No treatment for the first 28 days of the study. B/F/TAF tablet once daily for the last 28 days of the study (day 44-72).
Research bloods, endocrine profiles, weight and urine samples will be collected at baseline, as well as day 28, 44, and 72 to enable comparative analyses.
Participants will be closely monitored whilst taking the study medications. Participants will exit the study 72 days post-randomisation, with a follow-up call 28 days after exiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomised to start on Biktarvy tablet once daily OR no treatment for the first 28 day dosing phase of the study then will cross over to the alternative for the second dosing phase, following a 2 week washout period (equivalent to 5+ B/F/TAF elimination half-lives).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BIKTARVY 50Mg-200Mg-25Mg TabletBiktarvy - one tablet once daily, orally administered for the first 28 days of the study. No treatment for the last 44 days of the study. |
| Arm 2 | Experimental | Drug: BIKTARVY 50Mg-200Mg-25Mg TabletNo treatment for the first 28 days of the study. Biktarvy - one tablet once daily, orally administered for the last 28 days of the study (day 44-72). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Willing and able to provide informed consent
- Cis-Male and Cis-Female healthy subjects without underlying conditions
- Cis-Male and Cis-Female subjects with recruitment stratified to include at least 6 female subjects and at least 6 subjects of black Africa origin
- Subjects must have documented negative HIV serology by ELISA and P24 antigen and not receiving anti-HIV pre-exposure prophylaxis (PreP)
- Subjects must be clinically well volunteers aged between 18 to 60 years with BMI <30 kg/m2 but >18 kg/m2
Key exclusion criteria (22 listed)
- Subjects with a waist hip ratio > 0.97 or BMI > 30kg/m2 and BMI <18 kg/m2 will be excluded
- Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- Diabetes mellitus, other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension. Subject with HbA1c >42 mmol/mol will be excluded.
- History or presence of allergy to the B/F/TAF
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 TabletAlso: BIC/FTC/TAF, BictegravirA three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide taken once daily, orally | Drug | Arm 1, Arm 2 |
Primary outcome
Change in insulin sensitivity in participants from baseline to end of study between two crossover groups
Time frame: Baseline, day 28, 44, and 72 for both groups
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
7 secondary outcomes
Effect of Biktarvy on adipocytokines
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on fasting ghrelin
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on pituitary hormones
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on lipid profile including lipid fractions
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on changes in indirect calorimetry
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on changes in food intake
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on quality of sleep
Time frame: Baseline, day 28, 44, and 72 for both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.
Ana Milinkovic principal investigator
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with HIV-1-infection, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 25 inclusion and 22 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: finished, as of the sponsor's last update on 10 Dec 2024. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity in participants from baseline to end of study between two crossover groups (time frame: Baseline, day 28, 44, and 72 for both groups). 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 Dec 2024.