HIVPhase 4NCT02285374
Efavirenz to Dolutegravir Switch in Patients With CNS Toxicity
A Phase 4 study testing Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the combination pill, Atripla® is a recommended firstline regimen for the treatment of Human Immunodeficiency Virus-1 (HIV- 1) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female aged 18 years or older
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents one of which is EFV, for at least 12 weeks
- No previous exposure to integrase inhibitors
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- Has an HIV-plasma viral load at screening <400 copies/mL (single re-test allowed)
- Has a CD4 cell count at screening >50 cells/mm3
- Estimated glomerular filtration rate (MDRD) >50 ml/min.
- Has symptomatic CNS related toxicity associated with EFV at least Grade 2 by ACTG criteria
- If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial.
Who cannot join
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- Alanine aminotransferase (ALT) greater than or equal to 5 times the upper limit of normal (ULN), OR ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
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- Any investigational drug within 30 days prior to the trial drug administration
- Has received dolutegravir in the past
- Any clinical evidence of baseline resistance mutations
- History or presence of allergy to DTG or excipients (D-Mannitol, Microcystalline Cellulose, Povidone, Croscarmellose Sodium, Sodium Stearyl Fumarate, Talc, white film coat)
- Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
- Moderate or severe renal impairment (creatinine clearance < 50ml/min by Cockroft-Gault method)
- If female, she is pregnant or breastfeeding
- 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 drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir
This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the combination pill, Atripla® is a recommended firstline regimen for the treatment of Human Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also referred to as antiretroviral therapy.
Toxicity is the most common reason for modification of firstline therapy. Central Nervous System (CNS) side effects such as difficulty with sleeping \& bad dreams are common side effect of Efavirenz based therapy and is one of the most frequent reasons for switching or discontinuing highly active antiretroviral therapy.
Read more
Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to Efavirenz in other clinical studies, where patients were starting HIV treatment for the first time, or switching from other agents.
The purpose of the study is to investigate the benefits of switching away from Eefavirenz (in combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).
Read the detailed description
The main aim of this study is to investigate the benefits of switching from Efavirenz (taken in combination with Kivexa®or as part of the combination pill, Atripla®) in patients with Central Nervous System (CNS) side effects (such as difficulty with sleeping, bad dreams etc). The study aims to investigate the effect of switching Efavirenz to Dolutegravir while continuing Truvada (tenofovir plus emtricitabine, two constituents of Atripla) or Kivexa. Dolutegravir will be the only new component of the combination.
In addition to the aims stated above, the study also aims:
To investigate whether switching to dolutegravir based combination Antiretroviral Therapy (cART) is associated with resolution of CNS toxicity (determined by CNS questionnaire) at 12 weeks post switch To investigate continued virological suppression at levels of <400 and <50 copies/ml in individuals switching to dolutegravircontaining cART at 4 and 12 weeks post switch To investigate changes in cluster of differentiation 4+ (CD4+) cell count in individuals switching to dolutegravircontaining cART over 12 weeks post switch To investigate the safety (laboratory and non CNS adverse events) of switching to dolutegravir based cART over 12 weeks post switch To investigate changes in quality of life in individuals switching to dolutegravir based cART as assessed by Quality of life (EuroQOL) questionnaires over 12 weeks post switch To investigate the impact of switching to dolutegravir based CART on anxiety and depression (as determined by Hospital Anxiety and Depression Score (HADS) over 12 weeks post switch To investigate changes in quality of sleep in individuals switching to dolutegravir based cART as per standardized sleep questionnaire at 4 and 12 weeks post switch To assess the impact of switching to dolutegravir based cART on adherence by standard questionnaire over 12 weeks post switch To investigate changes in neuropsychiatric function in individuals switching to dolutegravir based cART by CogState battery and Instrumental Activities of Daily Life (IADL) questionnaire over 12 weeks post switch To investigate changes in fasting cholesterol and triglycerides in individuals switching to dolutegravir based cART over 12 weekspost switch To investigate Efavirenz (EFV) plasma decay and its impact on Dolutegravir (DTG) concentrations following the switch (Maximum Concentration (Cmax), Minimum Concentration (Cmin), Area Under the concentration-time Curve (AUC) at weeks 1, 2 and 3 post switch) To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure To assess changes in the levels of tryptophan, kynurenine, kynurenine/tryptophan ratio, neopterin, tumour necrosis factorα and interferonγ in plasma following treatment switch from efavirenz to dolutegravir.
To investigate the relationship between the immune activation biomarkers and the kynurenine/tryptophan ratio at baseline and post switch.
To investigate the relationship between the kynurenine/tryptophan ratio and measures of CNS toxicity and neurocognitive impairment at baseline and postswitch.
- Conditions
- HIV
- Being tested
- Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovirDrug
Also called Tivicay®, efavirenz, Atripla®
Arm 1: Switch efavirenz to dolutegravir immediately (at baseline) for 12 weeks Arm 2: Continue on pre-study regimen (unchanged) for 4 weeks and then switch efavirenz to dolutegravir for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Truvada (tenofovir 245mg/emtricitabine 200mg) or Kivexa (abacavir 600mg/lamivudine 300mg) one tablet once daily plus Dolutegravir 50mg (one tablet) once daily Receives: Drug: Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir |
| Arm 2 | Experimental | Atripla (efavirenz 600mg, emtricitabine 200mg, tenofovir 245mg) one tablet once daily, or Truvada (tenofovir 245mg/emtricitabine 200mg) or Kivexa (abacavir 600mg/lamivudine 300mg) one tablet once daily plus efavirenz 600mg one tablet once daily for 4 weeks. At week 4, efavirenz is switched to Dolutegravir 50mg (one tablet) once daily Receives: Drug: Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of neuropsychiatric and central nervous system (CNS) toxicity
The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on EFV Summary of Product Characteristics (SPC) and graded based on the ACTG adverse event scale) after 4 weeks of dual N(t)RTI plus DTG therapy:
- Sum total of all grades of CNS adverse events
- Median number of AIDS Clinical Trial Group (ACTG) grade 2-3 CNS adverse events Results 4 weeks post switch for each arm will be compared with baseline results and week 4 results will be compared between arms (ie 4 weeks post switch for arm 1 and day of switch for arm 2.).
Measured: 4 weeks post switch, day1
Secondary outcomes (15)
Rate of neuropsychiatric and central nervous system (CNS) toxicity
The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on EFV SPC and graded based on the ACTG adverse event scale) after 12 weeks of dual Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (N(t)RTI) plus DTG therapy:
- Proportion of subjects with ACTG grade 2-3 events
- Sum total of all grades of CNS adverse events
- Median number of ACTG grade 2-3 CNS adverse events Results 12 weeks post switch for each arm will be compared with baseline results.
Measured: 12 weeks post switch, day1
Virologic suppression
- Proportion of subjects maintaining virologic suppression to <50 and <400 copies/ml, 4 and 12 weeks post switch to dual N(t)RTI plus DTG
Measured: 4 and 12 weeks post switch, day1
CD4 cell count and %
Change in CD4 cell count and % from baseline compared with 4 and 12 weeks post switch to dual N(t)RTI plus DTG
Measured: 4 and 12 weeks post switch, day1
Quality of life
Changes in quality of life as assessed by Quality of life EuroQOL questionnaires at baseline, 4 and 12 weeks post switch
Measured: 4 and 12 weeks post switch, day1
CNS toxicity
Change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score at 4 and 12 weeks post switch to dual N(t)RTI plus DTG therapy, each compared with baseline
Measured: 4 and 12 weeks post switch, day1
Sleep
Change in sleep from baseline compared with weeks 4 and 12 post switch to dual N(t)RTI plus DTG therapy, as determined by the Pittsburgh Sleep Score
Measured: 4 and 12 weeks post switch, day1
Adherence
Change from baseline in adherence after 4 and 12 weeks of dual N(t)RTI plus DTG therapy as measured by the Medication Adherence Self-Report Inventory (M-MASRI) questionnaire
Measured: 4 and 12 weeks post switch, day1
Neurocognitive assessment
Change from baseline in NeuroCognitive (NC) function after 4, and 12 weeks of dual N(t)RTI plus DTG therapy as determined by computerised NC assessment (CogState) and Instrumental Activities of Daily Life (IADL) questionnaire
Measured: 4 and 12 weeks post switch, day1
Cholestrol levels
Change from baseline in median fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after switching to dual N(t)RTI plus DTG therapy at 4 and 12 weeks post switch
Measured: 4 and 12 weeks post switch, day1
Laboratory values
Proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 4 and 12 weeks of dual N(t)RTI plus DTG therapy compared with baseline and proportion of patients with grade 2-4 non-CNS adverse events after 4 and 12 weeks of dual N(t)RTI plus DTG therapy compared with baseline
Measured: 4 and 12 weeks post switch, day1
Efavirenz plasma concentration and Dolutegravir pharmacokinetics
Efavirenz plasma concentration decay and DTG Pharmacokinetics (PK) (Cmax, Cmin, AUC) at weeks 1, 2 and 3 post switch
Measured: 1, 2 and 3 weeks post switch, day1
Protein levels
To assess changes in the levels of Triptophan (TRP), Kynurenic (KYN), KYN/TRP ratio, neomycin (NEO), Tumor Necrosis Factor (TNF-α) and Interferon (IFN-γ) in plasma at baseline/time of switch and 12 wks post-switch for all patients.
Measured: 12 weeks post switch, day1
Difference in protein levels between the 2 arms
To assess differences between the immediate switch and delayed switch groups with regards to changes in the levels of TRP, KYN, KYN/TRP ratio, NEO, TNF-α and IFN-γ in plasma at baseline/time of switch and 12 wks post-switch
Measured: 12 weeks post switch, day1
Relationship between immune activation markers and protein ratio
To investigate the relationship between the IA biomarkers and the KYN/TRP ratio at baseline and post-switch.
Measured: Baseline and post switch, day1
Relationship between protein ratio and CNS toxicity and neurocognitive impairment
To investigate the relationship between the KYN/TRP ratio and measures of CNS toxicity and NCI at baseline and post-switch.
Measured: Baseline and post switch, day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, MD, Principal investigator, St Stephen's AIDS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285374
- Sponsor's protocol ID
- SSAT 056
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir
- ClinicalTrials.gov ID
- NCT02285374
- Acronym / sponsor ID
- SSAT 056
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Nov 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.
This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the combination pill, Atripla® is a recommended firstline regimen for the treatment of Human Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also referred to as antiretroviral therapy.
Toxicity is the most common reason for modification of firstline therapy. Central Nervous System (CNS) side effects such as difficulty with sleeping \& bad dreams are common side effect of Efavirenz based therapy and is one of the most frequent reasons for switching or discontinuing highly active antiretroviral therapy.
Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to Efavirenz in other clinical studies, where patients were starting HIV treatment for the first time, or switching from other agents.
The purpose of the study is to investigate the benefits of switching away from Eefavirenz (in combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).
Detailed description
The main aim of this study is to investigate the benefits of switching from Efavirenz (taken in combination with Kivexa®or as part of the combination pill, Atripla®) in patients with Central Nervous System (CNS) side effects (such as difficulty with sleeping, bad dreams etc). The study aims to investigate the effect of switching Efavirenz to Dolutegravir while continuing Truvada (tenofovir plus emtricitabine, two constituents of Atripla) or Kivexa. Dolutegravir will be the only new component of the combination.
In addition to the aims stated above, the study also aims:
To investigate whether switching to dolutegravir based combination Antiretroviral Therapy (cART) is associated with resolution of CNS toxicity (determined by CNS questionnaire) at 12 weeks post switch To investigate continued virological suppression at levels of <400 and <50 copies/ml in individuals switching to dolutegravircontaining cART at 4 and 12 weeks post switch To investigate changes in cluster of differentiation 4+ (CD4+) cell count in individuals switching to dolutegravircontaining cART over 12 weeks post switch To investigate the safety (laboratory and non CNS adverse events) of switching to dolutegravir based cART over 12 weeks post switch To investigate changes in quality of life in individuals switching to dolutegravir based cART as assessed by Quality of life (EuroQOL) questionnaires over 12 weeks post switch To investigate the impact of switching to dolutegravir based CART on anxiety and depression (as determined by Hospital Anxiety and Depression Score (HADS) over 12 weeks post switch To investigate changes in quality of sleep in individuals switching to dolutegravir based cART as per standardized sleep questionnaire at 4 and 12 weeks post switch To assess the impact of switching to dolutegravir based cART on adherence by standard questionnaire over 12 weeks post switch To investigate changes in neuropsychiatric function in individuals switching to dolutegravir based cART by CogState battery and Instrumental Activities of Daily Life (IADL) questionnaire over 12 weeks post switch To investigate changes in fasting cholesterol and triglycerides in individuals switching to dolutegravir based cART over 12 weekspost switch To investigate Efavirenz (EFV) plasma decay and its impact on Dolutegravir (DTG) concentrations following the switch (Maximum Concentration (Cmax), Minimum Concentration (Cmin), Area Under the concentration-time Curve (AUC) at weeks 1, 2 and 3 post switch) To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure To assess changes in the levels of tryptophan, kynurenine, kynurenine/tryptophan ratio, neopterin, tumour necrosis factorα and interferonγ in plasma following treatment switch from efavirenz to dolutegravir.
To investigate the relationship between the immune activation biomarkers and the kynurenine/tryptophan ratio at baseline and post switch.
To investigate the relationship between the kynurenine/tryptophan ratio and measures of CNS toxicity and neurocognitive impairment at baseline and postswitch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovirTruvada (tenofovir 245mg/emtricitabine 200mg) or Kivexa (abacavir 600mg/lamivudine 300mg) one tablet once daily plus Dolutegravir 50mg (one tablet) once daily |
| Arm 2 | Experimental | Drug: Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovirAtripla (efavirenz 600mg, emtricitabine 200mg, tenofovir 245mg) one tablet once daily, or Truvada (tenofovir 245mg/emtricitabine 200mg) or Kivexa (abacavir 600mg/lamivudine 300mg) one tablet once daily plus efavirenz 600mg one tablet once daily for 4 weeks. At week 4, efavirenz is switched to Dolutegravir 50mg (one tablet) once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is male or female aged 18 years or older
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents one of which is EFV, for at least 12 weeks
Key exclusion criteria (15 listed)
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- Alanine aminotransferase (ALT) greater than or equal to 5 times the upper limit of normal (ULN), OR ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin)
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 |
|---|---|---|
| Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovirAlso: Tivicay®, efavirenz, Atripla®Arm 1: Switch efavirenz to dolutegravir immediately (at baseline) for 12 weeks Arm 2: Continue on pre-study regimen (unchanged) for 4 weeks and then switch efavirenz to dolutegravir for 12 weeks | Drug | Arm 1, Arm 2 |
Primary outcome
Rate of neuropsychiatric and central nervous system (CNS) toxicity
Time frame: 4 weeks post switch, day1
The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on EFV Summary of Product Characteristics (SPC) and graded based on the ACTG adverse event scale) after 4 weeks of dual N(t)RTI plus DTG therapy: * Sum total of all grades of CNS adverse events * Median number of AIDS Clinical Trial Group (ACTG) grade 2-3 CNS adverse events Results 4 weeks post switch for each arm will be compared with baseline results and week 4 results will be compared between arms (ie 4 weeks post switch for arm 1 and day of switch for arm 2.).
15 secondary outcomes
Rate of neuropsychiatric and central nervous system (CNS) toxicity
Time frame: 12 weeks post switch, day1
Virologic suppression
Time frame: 4 and 12 weeks post switch, day1
CD4 cell count and %
Time frame: 4 and 12 weeks post switch, day1
Quality of life
Time frame: 4 and 12 weeks post switch, day1
CNS toxicity
Time frame: 4 and 12 weeks post switch, day1
Sleep
Time frame: 4 and 12 weeks post switch, day1
Adherence
Time frame: 4 and 12 weeks post switch, day1
Neurocognitive assessment
Time frame: 4 and 12 weeks post switch, day1
Cholestrol levels
Time frame: 4 and 12 weeks post switch, day1
Laboratory values
Time frame: 4 and 12 weeks post switch, day1
Efavirenz plasma concentration and Dolutegravir pharmacokinetics
Time frame: 1, 2 and 3 weeks post switch, day1
Protein levels
Time frame: 12 weeks post switch, day1
Difference in protein levels between the 2 arms
Time frame: 12 weeks post switch, day1
Relationship between immune activation markers and protein ratio
Time frame: Baseline and post switch, day1
Relationship between protein ratio and CNS toxicity and neurocognitive impairment
Time frame: Baseline and post switch, day1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
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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.
Mark Nelson, MD principal investigator
St Stephen's AIDS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir in people with HIV, run by St Stephens Aids 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 11 inclusion and 15 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 7 Nov 2014. 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 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 Nuno Morgado (+44 (0)20 3315 3765, nuno.morgado@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of neuropsychiatric and central nervous system (CNS) toxicity (time frame: 4 weeks post switch, day1). 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 7 Nov 2014.