HIVPhase 4NCT02098837
Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)
A Phase 4 study testing Dolutegravir in people with HIV, run by St Stephens Aids Trust at 33 sites in 6 countries.
Trial summary
The purpose of the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients' cardiovascular health (the health of their hearts). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV
- What is being tested?
- Dolutegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Apr 2014to 4 Dec 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient volunteers who meet all of the following criteria are eligible for this trial:
- Is male or female aged over 50, OR aged over 18 years with a Framingham risk score above 10%
- Has documented HIV-1 infection
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Has been receiving an ARV regimen containing a boosted PI (darunavir, atazanavir, lopinavir, or fosamprenavir) plus 2NRTIs for >24 weeks
Show all 9Show fewer
- Has stable virological suppression (plasma HIV-RNA <50 copies/mL for >24 weeks)
- If female and of childbearing potential, is using effective birth control methods and is willing to continue practising these birth control methods during the trial and for at least 2 weeks after the last dose of study medication. Note: Non-childbearing potential is defined as either post-menopausal (12 months of spontaneous amenorrhoea and ≥45 years) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy
- If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
Who cannot join
- Patients meeting 1 or more of the following criteria cannot be selected:
- Infected with HIV-2
- Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
- Any investigational drug within 30 days prior to the trial drug administration
Show all 19Show fewer
- History of exposure to any ARVs other than PIs or NRTIs except if switch was for tolerability/toxicity (NOTE: patients who have previously taken part in single drug trials for less than 14 days need not be excluded, or for virological failure with a genotypic resistance test without mutations
- Any prior evidence of primary viral resistance based on the presence of any major resistance-associated mutation to backbone NRTI
- History of prior virological failure,eg 2 consecutive HIV-1 RNA >50 c/ml -at or after week 32 following first ART initiation or confirmed rebound viraemia >200 copies/ml after having a VL of <50 copies/ml without resistance test or with significant mutations to any other ARV regimen (NOTE: Switch for toxicity or tolerability with wild type virus does not count as virological failure)
- Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
- History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ )3 x ULN and bilirubin ≥ 1.5 x ULN with > 35% direct bilirubin.
- Unstable liver disease (as defined by the presence of ascities, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), know biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones))
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- If female, currently pregnant or breastfeeding
- Opportunistic infection within 4 weeks prior to first dose of DTG
- Clinical decision that a switch of antiretroviral therapy should be immediate
- Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
- History or presence of allergy to the study drug or their components
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Spain8 sites
Universitario Alicante
Alicante, 03010
Hospital General Universitario de Elche
Alicante, 03203
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clinic Barcelona
Barcelona, 08036
Universitari de Bellvitge
Barcelona, 08907
IrsiCaixa
Barcelona, 08916
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
United Kingdom8 sites
Elton John Centre
Brighton, BN2 1ES
Southmead Hospital
Bristol, BS10 5NB
Bart's Hospital
London, E1 1BB
Royal Free Hospital
London, NW3 2QG
St Thomas Hospital
London, SE1 7EH
Chelsea & Westminster Hospital
London, Sw10 9NH
St Mary's Hospital
London, W2 1NY
Mortimer Market Centre
London, WC1E 6JB
France5 sites
Hopital de la Croix Rousse
Lyon, 69004
Service des Maladies Infectieuses et Tropicales du CHU de NANTES
Nantes, 44093
Hopital Saint Louis
Paris, 75010
Pitié-Salpêtrière Hospital
Paris, 75013
Hospital Bichat Claude-Bernard
Paris, 75018
Germany5 sites
Universitätsklinikum Bonn
Bonn, 53127
Universitätsklinikum Essen
Essen, 45147
Klinikum der Goethe-Universität Frankfurt
Frankfurt, 60590
ICH Infektiologisches Centrum Hamburg
Hamburg, 20146
Medizinische Hochschule Hannover
Hanover, 30625
Italy4 sites
Santa Maria Annunziata di Firenze
Florence, 50011
San Paolo Hospital
Milan, 20142
Azienda Ospedaliera - Polo Universitario 'Luigi Sacco'
Milan, 20157
Universitaria di Modena
Modena, 41124
Belgium3 sites
Insititute Of Tropical Medicine Antwerp
Antwerp, B-2000
CHU Saint-Pierre
Brussels, 100
Universitaire Ziekenhuis Gent
Ghent, 9000
About this study
Official title: An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir (DTG) in HIV Infected Patients With Stable Virological Suppression
The purpose of the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients' cardiovascular health (the health of their hearts). Patients are currently taking two other anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the boosted PI and dolutegravir more accurately, half of study participants will be switched to dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on the boosted PI.
Boosted PIs are associated with increased heart and circulation risk so it is hoped that switching from a boosted PI to dolutegravir will improve the health of the patients' hearts. Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in the US and Europe. Clinical trials using dolutegravir have found that it is effective at suppressing the HIV virus, and it is at least as effective as the other drugs.
This study will also investigate the safety (in terms of other side effects and the routine blood tests which the investigators ordinarily use to monitor patients' treatment) and monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in their blood, and CD4 count is a measure of a type of cell that is in their immune system. We also aim to improve patients' cardiovascular health in general by providing them with information on how to live a healthy lifestyle (eg improving their diet, stopping smoking etc).
Read the detailed description
Study Design: Randomised, non-inferiority strategic trial over 96 weeks with early or delayed switch from an ARV regimen containing a boosted PI plus 2 NRTIs to dolutegravir (DTG) plus 2 NRTIs in patients having achieved complete virological suppression for more than 24 weeks (HIV-1 RNA <50 c/ml). Patients will be randomised to switch at baseline or at 48 weeks.
Study visits will take place at screening, baseline, weeks 4 (immediate switch group only), 12, 24, 36, 48, 52 (deferred switch group only), 60, 72, 84 and 96, plus a follow up visit 28 days after the last dose of study medication.
Routine investigations will include viral load, CD4, haematology (including haemoglobin, white cell count and differential, platelets), biochemistry (including sodium, potassium, creatinine, albumin, glucose, ALT, ALP, total bilirubin, total cholesterol, HDL, LDL, triglycerides), quality of life questionnaires (EuroQL), urine sample (for haematuria, proteinuria, glycosuria, leukocytes, nitrate \& pregnancy test in WOCBP)
- Conditions
- HIV
- Being tested
- Dolutegravir
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Also called Tivicay
Dolutegravir 50mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Immediate switch | Active comparator | Patients will be randomised to switch from a boosted PI to dolutegravir at baseline. Receives: Drug: Dolutegravir |
| Deferred switch | Active comparator | Patients will be randomised to switch from a boosted PI to dolutegravir after 48 weeks. Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological suppression
Maintenance of virological suppression (ie HIV-1 RNA <50 c/ml) after 48 weeks
Measured: 48 weeks
Total cholesterol
Change from baseline in total cholesterol at week 48
Measured: 48 weeks
Secondary outcomes (11)
Virological Suppression
Maintenance of virological suppression (ie HIV-1 RNA <50 c/ml) at week 24 and 96
Measured: 24 - 96 weeks
CD4 count from baseline
Change in CD4 count from baseline to week 24, 48 and 96
Measured: 24 - 96 weeks
Baseline in total cholesterol
Change from baseline in total cholesterol at weeks 24 and 96
Measured: 24 - 96 weeks
Change from baseline to lipid values
Change from baseline to lipid values (LDL, HDL, triglycerides and TC:HDL ratio) and Framingham and DAD scores at weeks 24, 48 and 96
Measured: 24 - 96 weeks
Safety
Safety (clinical and laboratory adverse events) at weeks 24, 48 and 96
Measured: 24 - 96 weeks
Changes in markers of inflammation
Changes in markers of inflammation at baseline, week 48 and week 96
Measured: 48 - 96 weeks
Tolerability
Tolerability (EuroQoL questionnaire) at weeks 24, 48 and 96
Measured: 24 - 96 weeks
Changes in markers of coagulation
Changes in markers of coagulation at baseline, week 48 and week 96
Measured: 48 - 96 weeks
Changes in markers of endothelial dysfunction
Changes in markers of endothelial dysfunction at baseline, week 48 and week 96
Measured: 48 - 96 weeks
Change to arterial stiffness augmentation index at weeks 48 and 96
Change from baseline to arterial stiffness augmentation index at weeks 48 and 96
Measured: 48 - 96 weeks
Change to average thickness of common carotid artery walls at weeks 48 and 96
Change from baseline to average thickness of common carotid artery walls at weeks 48 and 96
Measured: 48 - 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Gatell, Dr, Principal investigator, Spanish healthcare system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098837
- Sponsor's protocol ID
- NEAT 22/SSAT 060
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2014
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sempere A, Assoumou L, Gonzalez-Cordon A, Waters L, Rusconi S, Domingo P, Gompels M, de Wit S, Raffi F, Stephan C, Masia M, Rockstroh J, Katlama C, Behrens GMN, Moyle G, Johnson M, Fox J, Stellbrink HJ, Guaraldi G, Florence E, Esser S, Gatell J, Pozniak A, Martinez E; NEAT 022 Study Group. Incidence of Hypertension and Blood Pressure Changes in Persons With Human Immunodeficiency Virus at High Risk for Cardiovascular Disease Switching From Boosted Protease Inhibitors to Dolutegravir: A Post-hoc Analysis of the 96-week Randomised NEAT-022 Trial. Clin Infect Dis. 2023 Oct 5;77(7):991-1009. doi: 10.1093/cid/ciad297.
PubMed 37207617Waters L, Assoumou L, Gonzalez-Cordon A, Rusconi S, Domingo P, Gompels M, de Wit S, Raffi F, Stephan C, Masia M, Rockstroh J, Katlama C, Behrens GMN, Moyle G, Johnson M, Fox J, Stellbrink HJ, Guaraldi G, Florence E, Esser S, Gatell JM, Pozniak A, Martinez E; NEAT 022 Study Group. Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk: A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial. Clin Infect Dis. 2023 Mar 4;76(5):861-870. doi: 10.1093/cid/ciac827.
PubMed 36259527Saumoy M, Sanchez-Quesada JL, Assoumou L, Gatell JM, Gonzalez-Cordon A, Guaraldi G, Domingo P, Giacomelli A, Connault J, Katlama C, Masia M, Ordonez-Llanos J, Pozniak A, Martinez E, Podzamczer D. Atherogenicity of low-density lipoproteins after switching from a protease inhibitor to dolutegravir: a substudy of the NEAT022 study. J Antimicrob Chemother. 2022 Jun 29;77(7):1980-1988. doi: 10.1093/jac/dkac117.
PubMed 35411401Gatell JM, Assoumou L, Moyle G, Waters L, Johnson M, Domingo P, Fox J, Martinez E, Stellbrink HJ, Guaraldi G, Masia M, Gompels M, De Wit S, Florence E, Esser S, Raffi F, Stephan C, Rockstroh J, Giacomelli A, Vera J, Bernardino JI, Winston A, Saumoy M, Gras J, Katlama C, Pozniak AL; European Network for AIDS Treatment 022 (NEAT022) Study Group. Immediate Versus Deferred Switching From a Boosted Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age >/=50 Years: Final 96-Week Results of the NEAT022 Study. Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.
PubMed 29912307
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir (DTG) in HIV Infected Patients With Stable Virological Suppression
- ClinicalTrials.gov ID
- NCT02098837
- Acronym / sponsor ID
- NEAT 22/SSAT 060
- Conditions
- HIV
- Keywords
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 28 Mar 2014 (estimated)
- 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 the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients' cardiovascular health (the health of their hearts). Patients are currently taking two other anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the boosted PI and dolutegravir more accurately, half of study participants will be switched to dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on the boosted PI.
Boosted PIs are associated with increased heart and circulation risk so it is hoped that switching from a boosted PI to dolutegravir will improve the health of the patients' hearts. Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in the US and Europe. Clinical trials using dolutegravir have found that it is effective at suppressing the HIV virus, and it is at least as effective as the other drugs.
This study will also investigate the safety (in terms of other side effects and the routine blood tests which the investigators ordinarily use to monitor patients' treatment) and monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in their blood, and CD4 count is a measure of a type of cell that is in their immune system. We also aim to improve patients' cardiovascular health in general by providing them with information on how to live a healthy lifestyle (eg improving their diet, stopping smoking etc).
Detailed description
Study Design: Randomised, non-inferiority strategic trial over 96 weeks with early or delayed switch from an ARV regimen containing a boosted PI plus 2 NRTIs to dolutegravir (DTG) plus 2 NRTIs in patients having achieved complete virological suppression for more than 24 weeks (HIV-1 RNA <50 c/ml). Patients will be randomised to switch at baseline or at 48 weeks.
Study visits will take place at screening, baseline, weeks 4 (immediate switch group only), 12, 24, 36, 48, 52 (deferred switch group only), 60, 72, 84 and 96, plus a follow up visit 28 days after the last dose of study medication.
Routine investigations will include viral load, CD4, haematology (including haemoglobin, white cell count and differential, platelets), biochemistry (including sodium, potassium, creatinine, albumin, glucose, ALT, ALP, total bilirubin, total cholesterol, HDL, LDL, triglycerides), quality of life questionnaires (EuroQL), urine sample (for haematuria, proteinuria, glycosuria, leukocytes, nitrate \& pregnancy test in WOCBP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate switch | Active comparator | Drug: DolutegravirPatients will be randomised to switch from a boosted PI to dolutegravir at baseline. |
| Deferred switch | Active comparator | Drug: DolutegravirPatients will be randomised to switch from a boosted PI to dolutegravir after 48 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient volunteers who meet all of the following criteria are eligible for this trial:
Key exclusion criteria (19 listed)
- Patients meeting 1 or more of the following criteria cannot be selected:
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 |
|---|---|---|
| DolutegravirAlso: TivicayDolutegravir 50mg once daily | Drug | Deferred switch, Immediate switch |
Primary outcome
Virological suppression
Time frame: 48 weeks
Maintenance of virological suppression (ie HIV-1 RNA <50 c/ml) after 48 weeks
Total cholesterol
Time frame: 48 weeks
Change from baseline in total cholesterol at week 48
11 secondary outcomes
Virological Suppression
Time frame: 24 - 96 weeks
CD4 count from baseline
Time frame: 24 - 96 weeks
Baseline in total cholesterol
Time frame: 24 - 96 weeks
Change from baseline to lipid values
Time frame: 24 - 96 weeks
Safety
Time frame: 24 - 96 weeks
Changes in markers of inflammation
Time frame: 48 - 96 weeks
Tolerability
Time frame: 24 - 96 weeks
Changes in markers of coagulation
Time frame: 48 - 96 weeks
Changes in markers of endothelial dysfunction
Time frame: 48 - 96 weeks
Change to arterial stiffness augmentation index at weeks 48 and 96
Time frame: 48 - 96 weeks
Change to average thickness of common carotid artery walls at weeks 48 and 96
Time frame: 48 - 96 weeks
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 9 Apr 2018.
- Derived from this study: PubMed 37207617Sempere A, Assoumou L, Gonzalez-Cordon A, Waters L, Rusconi S, Domingo P, Gompels M, de Wit S, Raffi F, Stephan C, Masia M, Rockstroh J, Katlama C, Behrens GMN, Moyle G, Johnson M, Fox J, Stellbrink HJ, Guaraldi G, Florence E, Esser S, Gatell J, Pozniak A, Martinez E; NEAT 022 Study Group. Incidence of Hypertension and Blood Pressure Changes in Persons With Human Immunodeficiency Virus at High Risk for Cardiovascular Disease Switching From Boosted Protease Inhibitors to Dolutegravir: A Post-hoc Analysis of the 96-week Randomised NEAT-022 Trial. Clin Infect Dis. 2023 Oct 5;77(7):991-1009. doi: 10.1093/cid/ciad297.
- Derived from this study: PubMed 36259527Waters L, Assoumou L, Gonzalez-Cordon A, Rusconi S, Domingo P, Gompels M, de Wit S, Raffi F, Stephan C, Masia M, Rockstroh J, Katlama C, Behrens GMN, Moyle G, Johnson M, Fox J, Stellbrink HJ, Guaraldi G, Florence E, Esser S, Gatell JM, Pozniak A, Martinez E; NEAT 022 Study Group. Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk: A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial. Clin Infect Dis. 2023 Mar 4;76(5):861-870. doi: 10.1093/cid/ciac827.
- Derived from this study: PubMed 35411401Saumoy M, Sanchez-Quesada JL, Assoumou L, Gatell JM, Gonzalez-Cordon A, Guaraldi G, Domingo P, Giacomelli A, Connault J, Katlama C, Masia M, Ordonez-Llanos J, Pozniak A, Martinez E, Podzamczer D. Atherogenicity of low-density lipoproteins after switching from a protease inhibitor to dolutegravir: a substudy of the NEAT022 study. J Antimicrob Chemother. 2022 Jun 29;77(7):1980-1988. doi: 10.1093/jac/dkac117.
- Derived from this study: PubMed 29912307Gatell JM, Assoumou L, Moyle G, Waters L, Johnson M, Domingo P, Fox J, Martinez E, Stellbrink HJ, Guaraldi G, Masia M, Gompels M, De Wit S, Florence E, Esser S, Raffi F, Stephan C, Rockstroh J, Giacomelli A, Vera J, Bernardino JI, Winston A, Saumoy M, Gras J, Katlama C, Pozniak AL; European Network for AIDS Treatment 022 (NEAT022) Study Group. Immediate Versus Deferred Switching From a Boosted Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age >/=50 Years: Final 96-Week Results of the NEAT022 Study. Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.
- Individual participant dataSharing planned: Undecided
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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 Gatell, Dr principal investigator
Spanish healthcare system
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir in people with HIV, run by St Stephens Aids Trust at 33 sites in 6 countries.
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 9 inclusion and 19 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, United Kingdom, France, Germany, Italy and 1 more country. 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?
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?
Virological suppression (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098837, which also lists 4 linked publications.
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 9 Apr 2018.