Will HIV-positive individuals who have drug resistance and have suppressed amount of virus in the blood on protease inhibitor regimen still remain suppressed if switched to a regimen containing bictegravir, emtricitabine and tenofovir alafenamide?
| ISRCTN | ISRCTN44453201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44453201 |
| EudraCT/CTIS number | 2018-004732-30 |
| IRAS number | 257865 |
| Secondary identifying numbers | CPMS 42164, IRAS 257865 |
- Submission date
- 10/06/2019
- Registration date
- 19/06/2019
- Last edited
- 20/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
As HIV multiplies in the body, the virus sometimes changes form (mutates). Some HIV mutations that develop while a person is taking HIV medicines can lead to drug-resistant strains of HIV. Once drug resistance develops, HIV medicines that previously controlled a person’s HIV are no longer effective. In other words, the HIV medicines can't prevent the drug-resistant HIV from multiplying. Drug resistance can cause HIV treatment to fail. The aim of this study is to find out whether a new integrase inhibitor-based drug regimen is as effective as a regimen containing a protease inhibitor in controlling the multiplication of HIV virus which harbours resistance.
Who can participate?
Patients aged 18 and over who are HIV-positive and on effective antiretroviral treatment containing a protease inhibitor. Patients must have evidence that the virus is resistant to antiretroviral therapy.
What does the study involve?
Participants are randomly allocated to either continue on their current protease inhibitor-based regimen or switch to an integrase inhibitor-based regimen (tenofovir alafenamide/emtricitabine/bictegravir (Biktarvy) single tablet regimen). Participants continue on their allocated treatment for 24 weeks. At this point, if there is no difference in the response to both the regimens, all those who had remained on their protease-inhibitor based regimen are then switched to the new treatment and all participants are followed up for a further 24 weeks. No one in this study takes dummy tablets. All participants are on active treatment throughout the study. There are a total of eight scheduled study visits during the 48 weeks of the study, with a 30-day post-study treatment follow up call or standard of care visit.
What are the possible benefits and risks of participating?
The possible benefits include reduced cardiovascular risk (reduced risk of heart attacks and strokes) with continued suppression of the amount of virus in the blood, lower likelihood of interactions with other medications, and reduced number of tablets taken for HIV. Information gained from this study could lead to change in how doctors use the medication. Blood tests may cause discomfort and may leave a temporary bruise. Every effort will be made to minimise this. Because the study involves additional visits to the clinic, the researchers can reimburse reasonable travel expenses for those extra visits. When switching from one antiviral regimen to another, there is a small risk that the virus will not be controlled with the new regimen, hence the virus could develop resistance to the medications. Furthermore, the new regimen could cause new side effects. Viral load and side effects will be frequently and carefully monitored during this study to minimise these risks
Where is the study run from?
1. University Hospitals Sussex NHS Foundation Trust
2. Barts Health NHS Trust
3. Central and North West London NHS Trust
4. King's College Hospital NHS Foundation Trust
5. Chelsea and Westminster NHS Trust
6. Royal Free London NHS Foundation Trust
7. Guy's and St Thomas' NHS Foundation Trust
When is the study starting and how long is it expected to run for?
November 2018 to February 2023
Who is funding the study?
Gilead Sciences (USA)
Who is the main contact?
1. Ye To
y.to@bsms.ac.uk
2. Nicky Perry
n.perry@bsms.ac.uk
2. Dr Collins Iwuji
c.iwuji@bsms.ac.uk
Contact information
Scientific
Global Health & Infection Department
Brighton and Sussex Medical School
University of Sussex
Brighton
BN1 9RH
United Kingdom
 ORCID ID |
0000-0003-2045-1717 |
|---|---|
| Phone | +44 (0)7984878861 |
| c.iwuji@bsms.ac.uk |
Scientific
Brighton and Sussex Clinical Trials Unit (BSCTU)
Room 110 Watson Building
Village Way
Brighton
BN1 9PH
United Kingdom
| Phone | +44 (0)1273 641469 |
|---|---|
| n.perry@bsms.ac.uk |
Scientific
Clinical Trials Unit
BSMS
Watson Building
University of Brighton – Falmer Campus
Brighton
BN1 9PH
United Kingdom
| Phone | +44 1273641437 |
|---|---|
| N.Dailey@bsms.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A Phase IV, randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in virologically suppressed HIV-1 infected adults harbouring drug resistance mutations |
| Study acronym | PIBIK |
| Study objectives | Current study hypothesis as of 23/07/2021: This is a phase IV, multicentre, open-label, randomised two-arm pilot study to assess the safety and efficacy of switching from boosted protease inhibitor regimen to B/F/TAF single-tablet regimen in virologically suppressed HIV-1infected adults harbouring drug resistance mutations. Previous study hypothesis: This is a phase IV, multicentre, open-label, randomised two-arm pilot study to assess the safety and efficacy of switching from boosted protease inhibitor regimen to B/F/TAF single-tablet regimen in integrase Inhibitor-naïve, virologically suppressed HIV-1infected adults harbouring drug resistance mutations. |
| Ethics approval(s) | Approved 28/06/2019, London – Brighton & Sussex Research Ethics Committee (Health Research Authority, Ground Floor, Skipton House, 80 London Road, London SE1 6LH; Tel: +44 (0)20 797 22567; Email: NRESCommittee.SECoast-BrightonandSussex@nhs.net), ref: 19/LO/0905 |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus [HIV] disease |
| Intervention | HIV-positive individuals who meet the eligibility criteria for the trial will be identified by their doctor and informed about the study. They will be referred to the doctor in charge of the research in each site where they will be given more information about the study and be given the opportunity to study the patient information leaflet and ask questions. Only after that will patients be consented and recruited into the study. HIV-positive individuals will be randomised to either continue on their current protease inhibitor-based regimen or switch to an integrase inhibitor-based regimen (tenofovir alafenamide/emtricitabine/bictegravir (Biktarvy) single-tablet regimen). Participants will know which arm they fall into after the randomisation and which treatment they are taking. Participants will continue on their allocated treatment for 24 weeks. At this point, if there is no difference in the response to both the regimens, all those who had remained on their protease-inhibitor based regimen will then be switched to the new treatment and all participants will be followed up for a further 24 weeks. The study will continue until each person enrolled in the study has been followed up for 48 weeks from the time they joined the study. This will occur at different times for those involved depending on when they joined the study. No one in this trial will be on dummy tablets. All participants will be on active treatment throughout the study. There will be a total of eight scheduled study visits during the 48 weeks duration of the trial. Updated 15/01/2020: There will be a total of eight scheduled study visits during the 48 weeks duration of the trial, with a 30-day post-study treatment follow up call or standard of care visit. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Tenofovir alafenamide, emtricitabine, bictegravir |
| Primary outcome measure | Proportions of individuals with HIV RNA <50 copies/mL at 24 weeks will be estimated using pure virologic response (PVR). The percentage of participants with PVR for HIV-1 RNA cut-off at 50 copies/mL at Week 24 will be summarized. PVR will be assessed as follows: 1. On study treatment 2. No confirmed virologic rebound defined as: 2.1. HIV RNA ≥ 50 copies/mL on 2 consecutive visits 2.2. HIV-1 RNA ≥ 50 copies/mL during study followed by premature discontinuation Discontinuation prior to week 24 for reasons other than virologic rebound (i.e. no data in window and last HIV RNA < 50 copies/mL) are considered PVR Timepoint(s): End of the study |
| Secondary outcome measures | 1. Proportion of patients with HIV RNA <50 copies/mL at week 48 using PVR 2. Proportion of patients with HIV-1 RNA <50 copies/mL at weeks 24 and 48 using PVR in those with any archived resistance detected in proviral DNA 3. Emergence of new resistance mutations measured by population sequencing in participants with two consecutive viral load >50 copies/mL 2-3 weeks apart 4. Safety and tolerability of B/F/TAF FDC in participants switching from bPI-based regimens measured using laboratory parameters and clinical assessments at 48 weeks 5. Patient-reported outcomes: sleep quality measured using the Pittsburgh Sleep Quality Index and bothersome symptoms measured using the HIV symptom distress scale at baseline, weeks 24 and 48 6. Serum lipid concentrations measured using blood samples at baseline, weeks 24 and 48 7. HBA1c measured using blood samples at baseline, weeks 24 and 48 8. Weight and BMI measured using weighing scale for weight and measuring tape for height at baseline, weeks 24 and 48 |
| Overall study start date | 01/11/2018 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80-100; UK Sample Size: 80-100 |
| Key inclusion criteria | Current participant inclusion criteria as of 23/07/2021: 1. 18 years and above 2. On a bPI-based ART regimen with documented HIV-1 RNA <50 copies/mL for at least 6 months on current regimen and at screening (A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF), lamivudine (3TC) to emtricitabine (FTC), or splitting co-formulated tablets to their individual component or vice versa will not be considered true regimen changes) 3. Must have a historical genotype 4. Eligible drug resistance mutations in historical genotype include at least one of the following: 4.1. M184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S) 4.2. M184V/I alone (maximum of 20 participants with isolated M184V/I mutation with or without NNRTI mutations) 4.3. Up to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I 4.4. Any of the above with or without NNRTI mutations 5. If previous INSTI exposure, participants should not have experienced virological failure on the INSTI regimen. Site must provide viral load history during the time participant was on INSTI for Chief Investigator review and confirmation of eligibility. Participants who experienced one of the following whilst on INSTI regimen will be excluded: 5.1. Viral load ≥50 copies/ml on two consecutive occasions 5.2. A single “blip” viral load ≥500 copies/ml 5.3. 3 or more “blips” (viral load 50 -500 copies/ml) 6. No known INSTI mutations 7. Estimated GFR ≥ 50 mL/min (Cockcroft-Gault formula) 8. Have the following laboratory values at screening within 30 days prior to baseline (note: a single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results): 8.1. Alkaline phosphatase ≤ 3.0 x upper limit of normal (ULN) 8.2. AST and ALT ≤ 5.0 x ULN 8.3. Haemoglobin ≥9.0 g/dL (female) or ≥10.0 g/dL (male) 9. Provides written, informed consent to participate 10. Is willing to comply with the protocol requirements 11. If female and of child bearing potential and are willing to continue practising one of the following: 11.1. Must be using effective birth control methods, that is has an expected failure rate of <1% per year and willing to continue practicing these birth control measures during the trial and for at least 30 days after the end of the trial. Effective methods include IUD, combined pill, contraceptive injection, implant, IUS, contraceptive vaginal ring, contraceptive patches etc. 11.2. Must be truly abstinent from penile-vaginal intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 30 days after the end of the trial (When this is in line with the preferred and usual lifestyle of the participant.) Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception. Note: women who are postmenopausal for least 2 years, women with a total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential. 12. If male, and sexually-active with female partners of child bearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial. Previous participant inclusion criteria as of 15/01/2020: 1. 18 years and above 2. On a bPI-based ART regimen with at least one documented HIV-1 RNA < 50 copies/mL within the previous 6 months and at screening 3. Eligible drug resistance mutations in historical genotype include at least one of the following: 3.1. M184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S) 3.2. M184V/I alone (maximum of 20 participants with isolated M184V mutation with or without NNRTI mutations) 3.3. Up to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I 3.4. Any of the above with or without NNRTI mutations 4. No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) 5. No known INSTI mutations 6. Must have historical genotype 7. Estimated GFR > = 50 mL/min (Cockcroft-Gault formula) 8. Have the following laboratory values at screening within 30 days prior to baseline 8.1. Alkaline phosphatase < = 3.0 x upper limit of normal (ULN) 8.2. AST and ALT < = 5.0 x ULN 8.3. Hemoglobin > = 9.0 g/dL (if female) or > = 10.0 g/dL (if male) 9. Provides written, informed consent to participate 10. Is willing to comply with the protocol requirements 11. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and willing to continue practising these birth control measures during the trial and for at least 30 days after the end of the trial 12. If male, and sexually-active with female partners of childbearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial Previous inclusion criteria: 1. 18 years and above 2. Any nadir CD4 count and baseline VL 3. On a bPI-based ART regimen with at least one documented HIV-1 RNA < 50 copies/mL within the previous 6 months and at screening 4. Eligible drug resistance mutations in historical genotype include the following: 4.1. M184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S) 4.2. M184V/I alone 4.3. Up to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I 4.4. Any of the above with or without NNRTI mutations 5. No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) 6. No known INSTI mutations 7. Must have historical genotype 8. Estimated GFR > = 50 mL/min (Cockcroft-Gault formula) 9. Have the following laboratory values at screening within 30 days prior to baseline 9.1. Alkaline phosphatase < = 3.0 x upper limit of normal (ULN) 9.2. AST and ALT < = 5.0 x ULN 9.3. Hemoglobin > = 9.0 g/dL (if female) or > = 10.0 g/dL (if male) 10. Provides written, informed consent to participate 11. Is willing to comply with the protocol requirements 12. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and willing to continue practising these birth control measures during the trial and for at least 30 days after the end of the trial 13. If male, and sexually-active with female partners of childbearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial |
| Key exclusion criteria | Current participant exclusion criteria as of 23/07/2021: 1. Exclusion under drug resistance mutations include: 1.1. Presence of any of the following mutations: K65R/N/E 1.2. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y 1.3. Presence of INSTI mutations: H51Y, T66AIK, E92QGV, G118R, F121Y, E138KAT, G140ASC, Y143CRHKSGA, P145S, Q146P, S147G, Q148HKRN, S153YF, N155HSTD, S230R, R263K 1.4. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) 2. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) 3. An opportunistic illness within the 30 days prior to screening 4. Active tuberculosis infection 5. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine based therapies) 6. Current alcohol or substance use judged by the Investigator to potentially interfere with participants’ adherence to study procedure. 7. A history of malignancy of less than 2 years or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study. 8. Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection) 9. Any pre-existing physical or mental health condition which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants. Subjects considered to pose a significant risk of suicide should be excluded. 10. Any known allergies to the excipients of B/F/TAF FDC 11. Females who are pregnant (as confirmed by positive urine pregnancy test) 12. Females who are breastfeeding 13. Women of child bearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection) 14. Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct acting antivirals in study 15. Any concomitant medications that cannot be administered with TAF (i.e strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins) Previous participant exclusion criteria as of 15/01/2020: 1. Exclusion under drug resistance mutations include: 1.1. Presence of any of the following mutations: K65R/N/E 1.2. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y 1.3. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) 2. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) 3. An opportunistic illness within the 30 days prior to screening 4. Active tuberculosis infection 5. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 6. Current alcohol or substance use judged by the Investigator to potentially interfere with participants’ adherence to study procedure 7. A history of malignancy of less than 5 years or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study 8. Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection) 9. Any other clinical condition or prior therapy that will, in the opinion of the investigator, make the participant ineligible 10. Any known allergies to the excipients of B/F/TAF FDC 11. Females who are pregnant (as confirmed by positive urine pregnancy test) 12. Females who are breastfeeding 13. Women of childbearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection, in addition to barrier methods) 14. Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct-acting antivirals in study 15. Any concomitant medications that cannot be administered with TAF (i.e. strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins) Previous exclusion criteria: 1. Exclusion under drug resistance mutations include: 1.1. Presence of any of the following mutations: K65R/N/E 1.2. Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y 1.3. Three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) 2. Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) 3. An opportunistic illness within the 30 days prior to screening 4. Active tuberculosis infection 5. Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 6. Current alcohol or substance use judged by the Investigator to potentially interfere with subjects’ adherence to study procedure 7. A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study 8. Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection) 9. Any other clinical condition or prior therapy that will, in the opinion of the investigator, make the subject ineligible 10. Any known allergies to the excipients of B/F/TAF FDC 11. Females who are pregnant (as confirmed by positive urine pregnancy test) 12. Females who are breastfeeding 13. Women of childbearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection, in addition to barrier methods) 14. Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct-acting antivirals in study 15. Any concomitant medications that cannot be administered with TAF (i.e. strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins) |
| Date of first enrolment | 16/09/2019 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Eastern Road
Brighton
BN2 5BE
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Capper Street
London
WC1E 6JB
United Kingdom
London
SE5 9RS
United Kingdom
London
SW10 9NH
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Research & Enterprise
Brighton
BN1 9RH
England
United Kingdom
| Phone | +44 (0)1273 872748 |
|---|---|
| researchsponsorship@sussex.ac.uk | |
"ROR" |
https://ror.org/00ayhx656 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Gilead, Gilead Sciences, Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. The researchers aim to publish the protocol in a peer-reviewed journal and a copy of the paper will be uploaded once available 2. The results will be disseminated in peer-reviewed scientific journals and conference presentations |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Collins Iwuji (c.iwuji@bsms.ac.uk). Type of data: fully anonymised raw dataset When the data will become available and for how long: for 5 years from 01/01/2024 By what access criteria data will be shared including with whom: 1. The researcher requesting the data will need to sign a data use agreement 2. The data will only be processed for the stated statistical and research purposes 3. Data will not in any way be used for any administrative, proprietary or law enforcement purposes For what types of analyses, and by what mechanism: analysis will be for non-commercial use Whether consent from participants was obtained: PIBIK participants provide consent to the following statement during the informed consent process prior to study registration Comments on data anonymisation: all data provided will be anonymised Any ethical or legal restrictions: no, only fully anonymised data will be shared |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/07/2020 | 22/07/2020 | Yes | No |
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
20/09/2023: A link to the HRA research summary was added.
10/05/2023: The intention to publish date was changed from 30/05/2023 to 30/09/2023.
04/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2022 to 28/02/2023.
2. The intention to publish date was changed from 28/02/2024 to 30/05/2023.
3. A scientific contact was added.
23/07/2021: The following changes have been made:
1. The study contact details have been updated.
2. The scientific title has been changed from "A Phase IV, randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in integrase inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations" to "A Phase IV, randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in virologically suppressed HIV-1 infected adults harbouring drug resistance mutations".
3. The study hypothesis has been updated.
4. The recruitment end date has been changed from 30/04/2021 to 28/02/2022.
5. The overall trial end date has been changed from 30/04/2022 to 28/02/2023.
6. The intention to publish date has been changed from 29/04/2023 to 28/02/2024.
7. The target number of participants has changed from "Planned Sample Size: 100; UK Sample Size: 100" to "Planned Sample Size: 80-100; UK Sample Size: 80-100".
8. The participant inclusion criteria have been updated.
9. The participant exclusion criteria have been updated.
10. The trial participating centre "Brighton and Sussex University Hospitals NHS Trust" has been changed to "University Hospitals Sussex NHS Foundation Trust".
11. The plain English summary has been updated to reflect the changes above.
26/10/2020: IPD sharing statement added.
15/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 16/10/2020 to 30/04/2021.
2. The overall trial end date was changed from 31/10/2021 to 30/04/2022.
3. The intention to publish date was changed from 30/10/2022 to 29/04/2023.
4. Recruitment to this study is no longer paused.
22/07/2020: Publication reference added.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
16/01/2020: Contact details updated.
15/01/2020: The following changes were made to the trial record:
1. The study contacts, interventions, and inclusion and exclusion criteria were updated.
2. The recruitment start date was changed from 29/07/2019 to 16/09/2019.
3. The recruitment end date was changed from 28/07/2020 to 16/10/2020.
4. The trial participating centres were updated to remove University College London Hospitals NHS Foundation Trust and add Central and North West London NHS Trust.
10/10/2019: Ethics approval date added.
10/06/2019: Trial's existence confirmed by the NIHR.
