Acquired Immune Deficiency SyndromePhase 3D4TNCT02670772
Dose Optimisation of Stavudine for the Treatment of HIV Infection
A Phase 3 study testing Stavudine and Tenofovir Disoproxil Fumarate in people with Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus, run by Willem Daniel Francois Venter at 3 sites in 3 countries.
Trial summary
The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Immune Deficiency Syndrome, Human Immunodeficiency Virus
- What is being tested?
- Stavudine and Tenofovir Disoproxil Fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,077 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is male or female aged ≥18 years (upper limit of <65 years in India)
- Patient has a documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked immunosorbent assay HIV-1 antibody test) at screening or from previous records
- Patient has a life expectancy of ≥2 years in the opinion of the investigator
- Patient has a plasma HIV-1 RNA level >1000 copies/mL
- Patient has a plasma CD4 count ≤ 350 cells/mm3 using standard flow cytometry.
- Patient has the following clinical chemistry and haematological laboratory results:
Show all 17Show fewer
- Serum creatinine ≤1.5 mg/dL (133 μmol/L) and a calculated creatinine clearance level ≥60 mL/min according to the Cockcroft-Gault formula
- Serum alanine aminotransferase <5 × upper limit of normal (ULN)
- Serum aspartate aminotransferase <5 × ULN
- Serum lipase ≤1.5 × ULN
- Total bilirubin ≤1.5 mg/dL (25 μmol/L) unless felt by clinician to be due to Gilbert syndrome
- Haemoglobin ≥7.0 g/dLAbsolute neutrophil count ≥500/mm3
- Platelet count ≥50 000/mm3.
- Female patients of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectable, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, or sexual abstinence) while participating in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit Women Not of Childbearing Potential are women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
- Women of Childbearing Potential (WOCBP) - Any female who has experienced menarche and does not meet the criteria for "Women Not of Childbearing Potential".
- Patient has the ability to comprehend the full nature and purpose of the study, in the opinion of the investigator, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study
- Patient is informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study
Who cannot join
- Patients who have previously received treatment with any form of antiretroviral therapy, including preventing mother-to-child transmission regimens
- Patients who are taking and cannot discontinue the following prohibited concomitant medications at least 1 week prior to the baseline visit and for the duration of the study period:
- Any agents with significant nephrotoxic potential
- Probenecid
- Systemic chemotherapy agents
- Drugs that have significant interactions with EFV other than rifampicin Administration of any of the above medications should be discontinued at least 1 week prior to the baseline visit and for the duration of the study period.
Show all 15Show fewer
- Patients who are clinically unstable, in the investigator's opinion, should be stabilized prior to inclusion into this study and their baseline concomitant medications should be stable for at least 1 month (30 days) prior to enrolment. In addition, investigators should not anticipate changing dose levels or medications for the duration of the study. Patients who, in the investigator's opinion, require HIV-related prophylaxis (such as cotrimoxazole) and/or other HIV-related treatments (e.g. treatment for oral thrush, tuberculosis, etc) and who, in the investigator's opinion are clinically stable may have such treatment initiated or discontinued during the screening period. The 30-day waiting period will not apply to the latter.
- Patients who have a current history of drug or alcohol abuse that, in the opinion of the investigator, may be an impediment to patient adherence to the protocol
- Patients who have a medical history or evidence of gastrointestinal malabsorption syndrome, chronic nausea, or vomiting which may prevent patients receiving oral medication
- Patients who have participated in a study with an investigational drug within 60 days of screening or who are currently receiving treatment with any other investigational drug or device
- Patients who are hepatitis B surface antigen positive
- Patients with symptomatic peripheral neuropathies
- Female patients who are currently pregnant or breastfeeding
- Female patients desiring pregnancy during the next 2 years
- Patients who have a strong likelihood of relocating far enough to make access to the study site difficult
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
South Africa1 site
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196
Uganda1 site
The Infectious Disease Institute (IDI), Mulago Hospital Complex
Kampala, Kampala, 25641
About this study
Official title: A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1
The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment.
Read the detailed description
This is randomised, placebo-controlled, double-blind, parallel-group, multisite, study to demonstrate whether low dose stavudine (d4T) is non-inferior to tenofovir (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment. If so, this will allow approximately two people requiring antiretrovirals to be treated for the price of one, with the same outcomes at two years. This is of huge public health consequence in Southern Africa, where TDF and zidovudine (AZT) now consume the majority of the antiretroviral budget. Decreasing total drug doses of antiretroviral agents, while maintaining efficacy, represents an untapped possibility for decreasing costs and toxicity, if efficacy can be maintained. Stavudine (d4T), an NRTI, is currently the second most commonly used antiretroviral worldwide in developing countries. Stavudine is an ideal candidate for assessment because of low cost, widespread use, and co-formulation, albeit at a dose that has significant side effects. While well tolerated in the short term, dose-dependent medium and long-term side effects, namely lipoatrophy and peripheral neuropathy, are very common. lipoatrophy is insidious, largely irreversible, and highly stigmatising, These toxicities have lead to the withdrawal of Stavudine as a recommended drug in most countries that can afford an alternative, even in second and subsequent regimens; the World Health Organisation (WHO) recommends that countries, wherever possible, move away from using Stavudine. However, there are data that suggest a lower dose of Stavudine would be better tolerated than the currently recommended dose and will be as effective in suppressing viral load as currently preferred first-line drugs. Consented patients will be randomised into one of two treatment arms using the interactive voice response systems (IVRS). The study monitor will maintain current personal knowledge of the study through observation, review of study records and source documentation, and discussion of the conduct of the study with the principal investigator or sub investigator and staff. Data will be captured onto electronic data capture system and managed for completeness, consistency and accuracy. All study operations such as patient recruitment, data management, safety reporting will be guided by Standard Operating Procedure (SOP) documents. A total of 1068 male and female antiretroviral-naive patients infected with HIV-1 will be randomised in a 1:1 ratio (approximately 534 patients per treatment group) to Treatment Group 1 (d4T/3TC+EFV) or Treatment Group 2 (TDF/3TC+EFV). Approximately 15% of patients are expected not to be evaluable for the PP set, therefore resulting in 907 patients for the PP set. This will provide 90% power to show non-inferiority between the 2 treatment groups for the proportion of patients achieving the primary efficacy endpoint (undetectable plasma HIV-1 RNA levels [<50 copies/mL] at Week 48) for the PP set (and 94% power for the all-randomised set), using a non-inferiority margin of 10% and a 1-sided 2.5 significance level. The proportion of patients achieving the primary efficacy endpoint has been assumed to be 70% in both treatment groups. The sample size calculation has been adjusted to allow for stopping at 2 interim analyses.
- Being tested
- Stavudine, Tenofovir Disoproxil Fumarate
- Keywords
- Antiretroviral Agents
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StavudineDrug
Also called d4t
Stavudine 20mg twice daily for 96 weeks + Placebo 300mg once daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
Tenofovir Disoproxil FumarateDrug
Also called TDF
TDF 300mg once daily + Placebo 20mg twice daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| Stavudine | Active comparator | Stavudine 20mg twice daily for 96 weeks Receives: Drug: Stavudine |
| Tenofovir Disoproxil Fumarate | Active comparator | Tenofovir 300mg once daily for 96 weeks Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with undetectable plasma HIV-1 RNA levels
Measured: Week 48
Number of participants with adverse events related to treatment
Measured: Week 48
Secondary outcomes (4)
Number of patients with plasma HIV-1 RNA levels <200 copies
Measured: Week 96
Number of participants with abnormal Bone mineral density and fat distribution
Measured: Week 96
Number of participants with abnormal Bone mineral density.
Measured: Week 96
Number of participants with abnormal fat distribution
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Immune Deficiency SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Willem Daniel Francois Venter
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor-investigator, Willem Daniel Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Francois Venter, FCP (SA), Principal investigator, Wits Reproductive Health & HIV Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670772
- Sponsor's protocol ID
- WRHI001
- Other IDs
- BMGF
- Acronym
- D4T
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Draaijer M, Lalla-Edward ST, Venter WDF, Vos A. Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study. JMIR Form Res. 2020 Sep 30;4(9):e19138. doi: 10.2196/19138.
PubMed 32996891Venter WDF, Kambugu A, Chersich MF, Becker S, Hill A, Arulappan N, Moorhouse M, Majam M, Akpomiemie G, Sokhela S, Poongulali S, Feldman C, Duncombe C, Ripin DHB, Vos A, Kumarasamy N. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):224-233. doi: 10.1097/QAI.0000000000001908.
PubMed 30640204Vos AG, Chersich MF, Klipstein-Grobusch K, Zuithoff P, Moorhouse MA, Lalla-Edward ST, Kambugu A, Kumarasamy N, Grobbee DE, Barth RE, Venter WD. Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir. Retrovirology. 2018 Dec 14;15(1):77. doi: 10.1186/s12977-018-0460-z.
PubMed 30547820
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1
- ClinicalTrials.gov ID
- NCT02670772
- Acronym / sponsor ID
- D4T / WRHI001
- Keywords
- Antiretroviral Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Willem Daniel Francois VenterUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Feb 2016 (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 this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment.
Detailed description
This is randomised, placebo-controlled, double-blind, parallel-group, multisite, study to demonstrate whether low dose stavudine (d4T) is non-inferior to tenofovir (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment. If so, this will allow approximately two people requiring antiretrovirals to be treated for the price of one, with the same outcomes at two years. This is of huge public health consequence in Southern Africa, where TDF and zidovudine (AZT) now consume the majority of the antiretroviral budget. Decreasing total drug doses of antiretroviral agents, while maintaining efficacy, represents an untapped possibility for decreasing costs and toxicity, if efficacy can be maintained. Stavudine (d4T), an NRTI, is currently the second most commonly used antiretroviral worldwide in developing countries. Stavudine is an ideal candidate for assessment because of low cost, widespread use, and co-formulation, albeit at a dose that has significant side effects. While well tolerated in the short term, dose-dependent medium and long-term side effects, namely lipoatrophy and peripheral neuropathy, are very common. lipoatrophy is insidious, largely irreversible, and highly stigmatising, These toxicities have lead to the withdrawal of Stavudine as a recommended drug in most countries that can afford an alternative, even in second and subsequent regimens; the World Health Organisation (WHO) recommends that countries, wherever possible, move away from using Stavudine. However, there are data that suggest a lower dose of Stavudine would be better tolerated than the currently recommended dose and will be as effective in suppressing viral load as currently preferred first-line drugs. Consented patients will be randomised into one of two treatment arms using the interactive voice response systems (IVRS). The study monitor will maintain current personal knowledge of the study through observation, review of study records and source documentation, and discussion of the conduct of the study with the principal investigator or sub investigator and staff. Data will be captured onto electronic data capture system and managed for completeness, consistency and accuracy. All study operations such as patient recruitment, data management, safety reporting will be guided by Standard Operating Procedure (SOP) documents. A total of 1068 male and female antiretroviral-naive patients infected with HIV-1 will be randomised in a 1:1 ratio (approximately 534 patients per treatment group) to Treatment Group 1 (d4T/3TC+EFV) or Treatment Group 2 (TDF/3TC+EFV). Approximately 15% of patients are expected not to be evaluable for the PP set, therefore resulting in 907 patients for the PP set. This will provide 90% power to show non-inferiority between the 2 treatment groups for the proportion of patients achieving the primary efficacy endpoint (undetectable plasma HIV-1 RNA levels [<50 copies/mL] at Week 48) for the PP set (and 94% power for the all-randomised set), using a non-inferiority margin of 10% and a 1-sided 2.5 significance level. The proportion of patients achieving the primary efficacy endpoint has been assumed to be 70% in both treatment groups. The sample size calculation has been adjusted to allow for stopping at 2 interim analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stavudine | Active comparator | Drug: StavudineStavudine 20mg twice daily for 96 weeks |
| Tenofovir Disoproxil Fumarate | Active comparator | Drug: Tenofovir Disoproxil FumarateTenofovir 300mg once daily for 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient is male or female aged ≥18 years (upper limit of <65 years in India)
- Patient has a documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked immunosorbent assay HIV-1 antibody test) at screening or from previous records
- Patient has a life expectancy of ≥2 years in the opinion of the investigator
- Patient has a plasma HIV-1 RNA level >1000 copies/mL
- Patient has a plasma CD4 count ≤ 350 cells/mm3 using standard flow cytometry.
Key exclusion criteria (15 listed)
- Patients who have previously received treatment with any form of antiretroviral therapy, including preventing mother-to-child transmission regimens
- Patients who are taking and cannot discontinue the following prohibited concomitant medications at least 1 week prior to the baseline visit and for the duration of the study period:
- Patients who are clinically unstable, in the investigator's opinion, should be stabilized prior to inclusion into this study and their baseline concomitant medications should be stable for at least 1 month (30 days) prior to enrolment. In addition, investigators should not anticipate changing dose levels or medications for the duration of the study. Patients who, in the investigator's opinion, require HIV-related prophylaxis (such as cotrimoxazole) and/or other HIV-related treatments (e.g. treatment for oral thrush, tuberculosis, etc) and who, in the investigator's opinion are clinically stable may have such treatment initiated or discontinued during the screening period. The 30-day waiting period will not apply to the latter.
- Patients who have a current history of drug or alcohol abuse that, in the opinion of the investigator, may be an impediment to patient adherence to the protocol
- Patients who have a medical history or evidence of gastrointestinal malabsorption syndrome, chronic nausea, or vomiting which may prevent patients receiving oral medication
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 |
|---|---|---|
| StavudineAlso: d4tStavudine 20mg twice daily for 96 weeks + Placebo 300mg once daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks | Drug | Stavudine |
| Tenofovir Disoproxil FumarateAlso: TDFTDF 300mg once daily + Placebo 20mg twice daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks | Drug | Tenofovir Disoproxil Fumarate |
Primary outcome
Number of participants with undetectable plasma HIV-1 RNA levels
Time frame: Week 48
Number of participants with adverse events related to treatment
Time frame: Week 48
4 secondary outcomes
Number of patients with plasma HIV-1 RNA levels <200 copies
Time frame: Week 96
Number of participants with abnormal Bone mineral density and fat distribution
Time frame: Week 96
Number of participants with abnormal Bone mineral density.
Time frame: Week 96
Number of participants with abnormal fat distribution
Time frame: Week 96
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 2 Feb 2016.
- Derived from this study: PubMed 32996891Draaijer M, Lalla-Edward ST, Venter WDF, Vos A. Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study. JMIR Form Res. 2020 Sep 30;4(9):e19138. doi: 10.2196/19138.
- Derived from this study: PubMed 30640204Venter WDF, Kambugu A, Chersich MF, Becker S, Hill A, Arulappan N, Moorhouse M, Majam M, Akpomiemie G, Sokhela S, Poongulali S, Feldman C, Duncombe C, Ripin DHB, Vos A, Kumarasamy N. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):224-233. doi: 10.1097/QAI.0000000000001908.
- Derived from this study: PubMed 30547820Vos AG, Chersich MF, Klipstein-Grobusch K, Zuithoff P, Moorhouse MA, Lalla-Edward ST, Kambugu A, Kumarasamy N, Grobbee DE, Barth RE, Venter WD. Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir. Retrovirology. 2018 Dec 14;15(1):77. doi: 10.1186/s12977-018-0460-z.
- 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.
Francois Venter, FCP (SA) principal investigator
Wits Reproductive Health & HIV Institute
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stavudine and Tenofovir Disoproxil Fumarate in people with Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus, run by Willem Daniel Francois Venter at 3 sites in 3 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 17 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: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, South Africa, Uganda. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with undetectable plasma HIV-1 RNA levels (time frame: Week 48). 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 NCT02670772, which also lists 3 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 2 Feb 2016.