HIV-1 InfectionPhase 4STATISNCT02057796
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
A Phase 4 study testing Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, ART (Atripla, Truvada, Efavirenz, Combivir) and Rifampin, isoniazid, pyrazinamide, ethambutol in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 countries.
Trial summary
In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, ART (Atripla, Truvada, Efavirenz, Combivir) and Rifampin, isoniazid, pyrazinamide, ethambutol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2014to Apr 2018
- 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
- Age ≥18 years;
- HIV-1 infection as documented at any time prior to trial entry, as per national testing procedures;
- CD4 <100 cells/mm3;
- No history of antiretroviral drug use (except transient ART for PMTCT);
- Able to correctly understand the trial and to sign the informed consent.
Who cannot join
- HIV-2 co-infection;
- Contra-indication to efavirenz;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >5 times the upper limit of normal;
- Creatinine clearance <50 ml/min;
- Overt evidence that TB treatment should be started immediately;
- History of TB treatment in the past 5 years;
Show all 9Show fewer
- Ongoing TB chemoprophylaxis (isoniazid preventive therapy);
- Any condition that would lead to differ ART initiation (e.g. acute condition requiring investigations and/or treatment prior to ART initiation);
- Current pregnancy or breastfeeding.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Côte d’Ivoire1 site
CePReF Centre de Prise en charge de Recherche et de Formation
Abidjan, Yopougon, 1954
About this study
Official title: Systematic Empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating Antiretroviral Therapy With CD4 Cell Counts <100/mm3: the STATIS Randomized Controlled Trial
In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency.
We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no overt evidence of TB will reduce the risk of death and invasive bacterial infections. This strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients with at least one positive test suggestive of TB.
Read the detailed description
Settings: Cambodia, Côte d'Ivoire, Uganda, Vietnam. Design: Multicentre, two-arm, unblinded randomized controlled superiority trial.
Objective: To compare the 24-week risk of death and occurrence of invasive bacterial infection between two experimental strategies in HIV-1 infected adults who start ART with a CD4 count <100/mm3: (i) continuous extensive TB screening during follow-up each time the patient present with symptoms, versus (ii) systematic empirical TB treatment started 2 weeks before ART initiation.
Trial strategies:
At inclusion, participants will be randomized 1:1 in two strategies of TB testing and treatment: extensive TB screening, or systematic empirical TB treatment.
Extensive TB screening (arm 1): In this arm:
- TB screening point-of-care tests (Xpert MTB/RIF®, urine LAM) and chest X-ray will be used extensively at randomisation (in all patients) and during follow-up (in patients with signs or symptoms suggestive of TB);
- Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH);
- ART (tenofovir(TDF)-lamivudine (3TC)/emtricitabine(FTC) or zidovudine (AZT)-lamivudine+ efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others.
Systematic empirical TB treatment (arm 2): In this arm:
- TB screening point-of-care tests will not be used;
- All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization; ART (tenofovir-lamivudine/emtricitabine or zidovudine-lamivudine+ efavirenz) will be started 2 weeks after TB treatment initiation.
Both strategies will apply to the first 24 weeks in the trial (intervention period).
From week-24 to week-48, the choice of TB tests and the prescription of TB treatment will be left upon the decision of the investigator in both trial arms.
Inclusion time: 24 months. Follow-up: each patient will be followed 48 weeks. Statistical analysis: the primary analysis will be intention to treat. It will compare the 24-week probability of death or invasive bacterial infection between arms.
Sample size: 1050 participants. This will allow demonstration of a 40% reduction in the 24-week probability of death or invasive bacterial infection in arm 2, compared to arm 1 (α 5%; 1-β 80%).
- Conditions
- HIV-1 Infection
- Being tested
- Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, ART (Atripla, Truvada, Efavirenz, Combivir), Rifampin, isoniazid, pyrazinamide, ethambutol
- Keywords
- HIV-1, Tuberculosis, Systematic empiric TB treatment, ART, TB diagnosis, Xpert MTB/RIF®, Urine LAM
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert MTB/RIF®, Determine TB LAM, Chest X-rayDevice
The following point-of-care TB tests will be systematically performed:
Xpert MTB/RIF® on sputum (in all patients able to provide sputum; no sputum induction will be requested in others), Urine LAM (all patients). Depending on clinical presentation, Xpert MTB/RIF® will also be performed on any relevant extra-pulmonary specimen.
TB treatment will depend on the result of the tests:
Criteria met for confirmed or probable TB : TB treatment will be initiated immediately (Visit 1) followed by ART initiation 2 weeks later (Visit 2); No evidence of confirmed or probable TB: ART will be started immediately (Visit 1).
ART (Atripla, Truvada, Efavirenz, Combivir)Drug
Also called ART
- ART (TDF-3TC/FTC or AZT-3TC + efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others.
- ART will be initiated 2 weeks after the onset of TB treatment (V2) for Arm 2
Rifampin, isoniazid, pyrazinamide, ethambutolDrug
Also called Systematic Empiric treatment
Arm 1: Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH); Arm 2: • All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization
| Study group | Role | What they receive |
|---|---|---|
| Xpert MTB/RIF®, Determine TB LAM, Chest X-ray | Experimental | Arm1 Extensive TB screening:
In this arm, point-of-care tests for TB will be used at randomization (in all patients) and at each scheduled or unscheduled follow-up visit (in patients with signs or symptoms suggestive of TB and no clear alternative diagnosis); TB treatment will only be prescribed to patients with a diagnosis of TB Receives: Device: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray; Drug: ART (Atripla, Truvada, Efavirenz, Combivir); Drug: Rifampin, isoniazid, pyrazinamide, ethambutol |
| Rifampin, isoniazid, pyrazinamide, ethambutol | Experimental | Arm 2: Systematic Empiric treatment (Rifampicin,isoniazid, pyrazinamide, ethambutol) ART
In this arm, all patients will start a systematic 6-month TB treatment at randomization. TB screening tests will not systematically be used neither at randomization nor while patients are on TB treatment. Receives: Drug: ART (Atripla, Truvada, Efavirenz, Combivir); Drug: Rifampin, isoniazid, pyrazinamide, ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality and incidence of invasive bacterial infections
The primary endpoint is the composite of (i) 24-week all-cause mortality and (ii) 24-week incidence of invasive bacterial infections
Measured: 24 weeks
Secondary outcomes (2)
Incidence of confirmed/probable/possible TB
Measured: 24 Weeks and 48 weeks
Incidence of grade 3 or 4 adverse events
Measured: 24 Weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- François-Xavier Blanc, MD, PhD, Principal investigator, Université de Nantes, Institut du thorax, CHU Nantes, FranceKouao Médard Serge Domoua, MD, Principal investigator, Service de Pneumologie, CHU de Treichville, Abidjan, Côte d'Ivoire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057796
- Sponsor's protocol ID
- ANRS 12290
- Acronym
- STATIS
- Status last verified
- Oct 2020
- First submitted
- 5 Feb 2014
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonnet M, Gabillard D, Domoua S, Muzoora C, Messou E, Sovannarith S, Nguyen DB, Badje A, Juchet S, Bunnet D, Borand L, Natukunda N, Tran TH, Anglaret X, Laureillard D, Blanc FX; Systematic empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely immunosuppressed HIV-infected adults initiating antiretroviral therapy with CD4 cell counts <100/mm3 (STATIS) Agence Nationale de Recherche sur le Sida et les hepatites virales (ANRS) 12290 Trial Team. High Performance of Systematic Combined Urine Liboarabinomannan Test and Sputum Xpert MTB/RIF for Tuberculosis Screening in Severely Immunosuppressed Ambulatory Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Jul 5;77(1):112-119. doi: 10.1093/cid/ciad125.
PubMed 36883573Blanc FX, Badje AD, Bonnet M, Gabillard D, Messou E, Muzoora C, Samreth S, Nguyen BD, Borand L, Domergue A, Rapoud D, Natukunda N, Thai S, Juchet S, Eholie SP, Lawn SD, Domoua SK, Anglaret X, Laureillard D; STATIS ANRS 12290 Trial Team. Systematic or Test-Guided Treatment for Tuberculosis in HIV-Infected Adults. N Engl J Med. 2020 Jun 18;382(25):2397-2410. doi: 10.1056/NEJMoa1910708.
PubMed 32558469
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating Antiretroviral Therapy With CD4 Cell Counts <100/mm3: the STATIS Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02057796
- Acronym / sponsor ID
- STATIS / ANRS 12290
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1, Tuberculosis, Systematic empiric TB treatment, ART, TB diagnosis, Xpert MTB/RIF®, Urine LAM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Feb 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.
In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency.
We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no overt evidence of TB will reduce the risk of death and invasive bacterial infections. This strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients with at least one positive test suggestive of TB.
Detailed description
Settings: Cambodia, Côte d'Ivoire, Uganda, Vietnam. Design: Multicentre, two-arm, unblinded randomized controlled superiority trial.
Objective: To compare the 24-week risk of death and occurrence of invasive bacterial infection between two experimental strategies in HIV-1 infected adults who start ART with a CD4 count <100/mm3: (i) continuous extensive TB screening during follow-up each time the patient present with symptoms, versus (ii) systematic empirical TB treatment started 2 weeks before ART initiation.
Trial strategies:
At inclusion, participants will be randomized 1:1 in two strategies of TB testing and treatment: extensive TB screening, or systematic empirical TB treatment.
Extensive TB screening (arm 1): In this arm:
- TB screening point-of-care tests (Xpert MTB/RIF®, urine LAM) and chest X-ray will be used extensively at randomisation (in all patients) and during follow-up (in patients with signs or symptoms suggestive of TB);
- Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH);
- ART (tenofovir(TDF)-lamivudine (3TC)/emtricitabine(FTC) or zidovudine (AZT)-lamivudine+ efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others.
Systematic empirical TB treatment (arm 2): In this arm:
- TB screening point-of-care tests will not be used;
- All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization; ART (tenofovir-lamivudine/emtricitabine or zidovudine-lamivudine+ efavirenz) will be started 2 weeks after TB treatment initiation.
Both strategies will apply to the first 24 weeks in the trial (intervention period).
From week-24 to week-48, the choice of TB tests and the prescription of TB treatment will be left upon the decision of the investigator in both trial arms.
Inclusion time: 24 months. Follow-up: each patient will be followed 48 weeks. Statistical analysis: the primary analysis will be intention to treat. It will compare the 24-week probability of death or invasive bacterial infection between arms.
Sample size: 1050 participants. This will allow demonstration of a 40% reduction in the 24-week probability of death or invasive bacterial infection in arm 2, compared to arm 1 (α 5%; 1-β 80%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xpert MTB/RIF®, Determine TB LAM, Chest X-ray | Experimental | Device: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, Drug: ART (Atripla, Truvada, Efavirenz, Combivir), Drug: Rifampin, isoniazid, pyrazinamide, ethambutolArm1 Extensive TB screening: In this arm, point-of-care tests for TB will be used at randomization (in all patients) and at each scheduled or unscheduled follow-up visit (in patients with signs or symptoms suggestive of TB and no clear alternative diagnosis); TB treatment will only be prescribed to patients with a diagnosis of TB |
| Rifampin, isoniazid, pyrazinamide, ethambutol | Experimental | Drug: ART (Atripla, Truvada, Efavirenz, Combivir), Drug: Rifampin, isoniazid, pyrazinamide, ethambutolArm 2: Systematic Empiric treatment (Rifampicin,isoniazid, pyrazinamide, ethambutol) ART In this arm, all patients will start a systematic 6-month TB treatment at randomization. TB screening tests will not systematically be used neither at randomization nor while patients are on TB treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- HIV-1 infection as documented at any time prior to trial entry, as per national testing procedures;
- CD4 <100 cells/mm3;
- No history of antiretroviral drug use (except transient ART for PMTCT);
- Able to correctly understand the trial and to sign the informed consent.
Key exclusion criteria (9 listed)
- HIV-2 co-infection;
- Contra-indication to efavirenz;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >5 times the upper limit of normal;
- Creatinine clearance <50 ml/min;
- Overt evidence that TB treatment should be started immediately;
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 |
|---|---|---|
| Xpert MTB/RIF®, Determine TB LAM, Chest X-rayThe following point-of-care TB tests will be systematically performed: Xpert MTB/RIF® on sputum (in all patients able to provide sputum; no sputum induction will be requested in others), Urine LAM (all patients). Depending on clinical presentation, Xpert MTB/RIF® will also be performed on any relevant extra-pulmonary specimen. TB treatment will depend on the result of the tests: Criteria met for confirmed or probable TB : TB treatment will be initiated immediately (Visit 1) followed by ART initiation 2 weeks later (Visit 2); No evidence of confirmed or probable TB: ART will be started immediately (Visit 1). | Device | Xpert MTB/RIF®, Determine TB LAM, Chest X-ray |
| ART (Atripla, Truvada, Efavirenz, Combivir)Also: ART* ART (TDF-3TC/FTC or AZT-3TC + efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others. * ART will be initiated 2 weeks after the onset of TB treatment (V2) for Arm 2 | Drug | Rifampin, isoniazid, pyrazinamide, ethambutol, Xpert MTB/RIF®, Determine TB LAM, Chest X-ray |
| Rifampin, isoniazid, pyrazinamide, ethambutolAlso: Systematic Empiric treatmentArm 1: Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH); Arm 2: • All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization | Drug | Rifampin, isoniazid, pyrazinamide, ethambutol, Xpert MTB/RIF®, Determine TB LAM, Chest X-ray |
Primary outcome
All-cause mortality and incidence of invasive bacterial infections
Time frame: 24 weeks
The primary endpoint is the composite of (i) 24-week all-cause mortality and (ii) 24-week incidence of invasive bacterial infections
2 secondary outcomes
Incidence of confirmed/probable/possible TB
Time frame: 24 Weeks and 48 weeks
Incidence of grade 3 or 4 adverse events
Time frame: 24 Weeks and 48 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 19 Oct 2020.
- Derived from this study: PubMed 36883573Bonnet M, Gabillard D, Domoua S, Muzoora C, Messou E, Sovannarith S, Nguyen DB, Badje A, Juchet S, Bunnet D, Borand L, Natukunda N, Tran TH, Anglaret X, Laureillard D, Blanc FX; Systematic empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely immunosuppressed HIV-infected adults initiating antiretroviral therapy with CD4 cell counts <100/mm3 (STATIS) Agence Nationale de Recherche sur le Sida et les hepatites virales (ANRS) 12290 Trial Team. High Performance of Systematic Combined Urine Liboarabinomannan Test and Sputum Xpert MTB/RIF for Tuberculosis Screening in Severely Immunosuppressed Ambulatory Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Jul 5;77(1):112-119. doi: 10.1093/cid/ciad125.
- Derived from this study: PubMed 32558469Blanc FX, Badje AD, Bonnet M, Gabillard D, Messou E, Muzoora C, Samreth S, Nguyen BD, Borand L, Domergue A, Rapoud D, Natukunda N, Thai S, Juchet S, Eholie SP, Lawn SD, Domoua SK, Anglaret X, Laureillard D; STATIS ANRS 12290 Trial Team. Systematic or Test-Guided Treatment for Tuberculosis in HIV-Infected Adults. N Engl J Med. 2020 Jun 18;382(25):2397-2410. doi: 10.1056/NEJMoa1910708.
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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.
François-Xavier Blanc, MD, PhD principal investigator
Université de Nantes, Institut du thorax, CHU Nantes, France
Kouao Médard Serge Domoua, MD principal investigator
Service de Pneumologie, CHU de Treichville, Abidjan, Côte d'Ivoire
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, ART (Atripla, Truvada, Efavirenz, Combivir) and Rifampin, isoniazid, pyrazinamide, ethambutol in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 4 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 5 inclusion and 9 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cambodia, Côte d’Ivoire, Uganda, Vietnam. 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?
All-cause mortality and incidence of invasive bacterial infections (time frame: 24 weeks). 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 NCT02057796, which also lists 2 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 19 Oct 2020.