HIV/AIDSNewHorizonNCT04194021
Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir
An observational study of HIV/AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 5 sites in 5 countries.
Trial summary
The objectives of this data collection activity are to: 1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR; 2. Read more about this study
- Who is it for?
- Ages Up to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- How many people
- 871 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Observational
- 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 Up to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients who ever received darunavir and/or etravirine before turning age 25 and residing in the following countries: Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, Zimbabwe.
Who may be able to join
- Ever received darunavir and/or etravirine.
- Under age 25.
- Residing in any of the following countries: Cameroon, Ethiopia, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe.
Who cannot join
- Above age 25.
- Residing in a country not participating in the New Horizons Collaborative.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Cameroon1 site
Elizabeth Glaser Pediatric AIDS Foundation/Cameroon
Yaoundé, Centre Region
Eswatini1 site
Elizabeth Glaser Pediatric AIDS Foundation/Eswatini
Mbabane, Hhohho Region
About this study
Official title: Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction
The objectives of this data collection activity are to:
- Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR;
- Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021;
- Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR;
- Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.
Read the detailed description
Janssen, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Partnership for Supply Chain Management (PFSCM), the Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International AIDS Society (IAS), and Right to Care have partnered to implement the New Horizons Collaborative to improve and scale-up pediatric HIV/AIDS care and treatment through increased awareness, research, health systems strengthening, and improved access to HIV/AIDS medicines. A primary source of darunavir (DRV) and etravirine (ETR) for pediatric populations in sub-Saharan Africa is through the New Horizons DRV/ETR Donation Program, which was launched in 2014. Under this program, Janssen provides DRV and/or ETR free of charge to eligible national HIV/AIDS programs in sub-Saharan Africa, for use in children and adolescents up to 25 years of age.
Countries currently participating in the New Horizons Collaborative include: Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Any country that applies and is approved for receipt of donated product will become eligible for this study when they begin offering donated product to patients.
Prior to the inception of the New Horizons Collaborative, no multi-country data were collected regarding the demographic or clinical characteristics of the target patient population (i.e., children, adolescents, and young people < 25 years in need of second- or third-line HIV/AIDS treatment). Therefore, the current activity proposes to collect cross-sectional demographic and clinical data at baseline and every six months for patients receiving DRV and/or ETR across participating New Horizons countries. This activity will comprise data abstraction of key demographic, clinical, laboratory and case history indicators and outcomes on each patient who ever received DRV and/or ETR.
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Antiretroviral therapy, Darunavir, Etravirine, Treatment-experienced HIV, Pediatrics, Adolescents, Young people, Drug resistance mutations, Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Uganda, Zambia, Zimbabwe, Viral load, Protease inhibitor
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical profile of patients who ever received darunavir and/or etravirine
Clinical and laboratory profiles of patients who ever received darunavir and/or etravirine
Measured: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Secondary outcomes (2)
Demographic profile of patients who ever received darunavir and/or etravirine
Age and gender of patients who ever received darunavir and/or etravirine
Measured: At initiation of darunavir and/or etravirine
Dynamics in HIV drug resistance mutations
Dynamics in HIV drug resistance mutations among patients who fail treatment
Measured: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Appolinaire Tiam, MBChB, MMed, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194021
- Sponsor's protocol ID
- EG0205
- Acronym
- NewHorizon
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2019
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clavel F, Hance AJ. HIV drug resistance. N Engl J Med. 2004 Mar 4;350(10):1023-35. doi: 10.1056/NEJMra025195. No abstract available.
PubMed 14999114Petersen ML, van der Laan MJ, Napravnik S, Eron JJ, Moore RD, Deeks SG. Long-term consequences of the delay between virologic failure of highly active antiretroviral therapy and regimen modification. AIDS. 2008 Oct 18;22(16):2097-106. doi: 10.1097/QAD.0b013e32830f97e2.
PubMed 18832873Vaz P, Augusto O, Bila D, Macassa E, Vubil A, Jani IV, Pillon R, Sandstrom P, Sutherland D, Giaquinto C, Jordan MR, Bertagnolio S. Surveillance of HIV drug resistance in children receiving antiretroviral therapy: a pilot study of the World Health Organization's generic protocol in Maputo, Mozambique. Clin Infect Dis. 2012 May;54 Suppl 4(Suppl 4):S369-74. doi: 10.1093/cid/cis006.
PubMed 22544205Puthanakit T, Aurpibul L, Oberdorfer P, Akarathum N, Kanjanavanit S, Wannarit P, Sirisanthana T, Sirisanthana V. Sustained immunologic and virologic efficacy after four years of highly active antiretroviral therapy in human immunodeficiency virus infected children in Thailand. Pediatr Infect Dis J. 2007 Oct;26(10):953-6. doi: 10.1097/INF.0b013e318125720a.
PubMed 17901804Bolton-Moore C, Mubiana-Mbewe M, Cantrell RA, Chintu N, Stringer EM, Chi BH, Sinkala M, Kankasa C, Wilson CM, Wilfert CM, Mwango A, Levy J, Abrams EJ, Bulterys M, Stringer JS. Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia. JAMA. 2007 Oct 24;298(16):1888-99. doi: 10.1001/jama.298.16.1888.
PubMed 17954540Sutcliffe CG, van Dijk JH, Bolton C, Persaud D, Moss WJ. Effectiveness of antiretroviral therapy among HIV-infected children in sub-Saharan Africa. Lancet Infect Dis. 2008 Aug;8(8):477-89. doi: 10.1016/S1473-3099(08)70180-4.
PubMed 18652994Reddi A, Leeper SC, Grobler AC, Geddes R, France KH, Dorse GL, Vlok WJ, Mntambo M, Thomas M, Nixon K, Holst HL, Karim QA, Rollins NC, Coovadia HM, Giddy J. Preliminary outcomes of a paediatric highly active antiretroviral therapy cohort from KwaZulu-Natal, South Africa. BMC Pediatr. 2007 Mar 17;7:13. doi: 10.1186/1471-2431-7-13.
PubMed 17367540Katabira ET, Oelrichs RB. Scaling up antiretroviral treatment in resource-limited settings: successes and challenges. AIDS. 2007 Jul;21 Suppl 4:S5-10. doi: 10.1097/01.aids.0000279701.93932.ef. No abstract available.
PubMed 17620753Janssens B, Raleigh B, Soeung S, Akao K, Te V, Gupta J, Vun MC, Ford N, Nouhin J, Nerrienet E. Effectiveness of highly active antiretroviral therapy in HIV-positive children: evaluation at 12 months in a routine program in Cambodia. Pediatrics. 2007 Nov;120(5):e1134-40. doi: 10.1542/peds.2006-3503. Epub 2007 Oct 22.
PubMed 17954553Arasteh K, Yeni P, Pozniak A, Grinsztejn B, Jayaweera D, Roberts A, Hoy J, De Meyer S, Vangeneugden T, Tomaka F. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14(6):859-64. doi: 10.3851/IMP1301.
PubMed 19812449Katlama C, Clotet B, Mills A, Trottier B, Molina JM, Grinsztejn B, Towner W, Haubrich R, Nijs S, Vingerhoets J, Woodfall B, Witek J. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15(7):1045-52. doi: 10.3851/IMP1662.
PubMed 21041921Imaz A, Llibre JM, Mora M, Mateo G, Camacho A, Blanco JR, Curran A, Santos JR, Caballero E, Bravo I, Gaya F, Domingo P, Rivero A, Falco V, Clotet B, Ribera E. Efficacy and safety of nucleoside reverse transcriptase inhibitor-sparing salvage therapy for multidrug-resistant HIV-1 infection based on new-class and new-generation antiretrovirals. J Antimicrob Chemother. 2011 Feb;66(2):358-62. doi: 10.1093/jac/dkq432. Epub 2010 Dec 14.
PubMed 21172789Fagard C, Colin C, Charpentier C, Rami A, Jacomet C, Yeni P, Vittecoq D, Katlama C, Molina JM, Descamps D, Chene G, Yazdanpanah Y; ANRS 139 TRIO Trial Group. Long-term efficacy and safety of raltegravir, etravirine, and darunavir/ritonavir in treatment-experienced patients: week 96 results from the ANRS 139 TRIO trial. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):489-93. doi: 10.1097/QAI.0b013e31824bb720.
PubMed 22293546Corrigan B, Mukui I, Mulenga L, Mthethwa N, Letsie M, Bruno S, Rakhmanina N. Characteristics of Treatment-experienced HIV-infected African Children and Adolescents Initiating Darunavir and/or Etravirine-based Antiretroviral Treatment. Pediatr Infect Dis J. 2018 Jul;37(7):669-672. doi: 10.1097/INF.0000000000001843.
PubMed 29140932
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction
- ClinicalTrials.gov ID
- NCT04194021
- Acronym / sponsor ID
- NewHorizon / EG0205
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Antiretroviral therapy, Darunavir, Etravirine, Treatment-experienced HIV, Pediatrics, Adolescents, Young people
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Dec 2019 (actual)
- 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 objectives of this data collection activity are to:
- Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR;
- Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021;
- Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR;
- Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.
Detailed description
Janssen, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Partnership for Supply Chain Management (PFSCM), the Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International AIDS Society (IAS), and Right to Care have partnered to implement the New Horizons Collaborative to improve and scale-up pediatric HIV/AIDS care and treatment through increased awareness, research, health systems strengthening, and improved access to HIV/AIDS medicines. A primary source of darunavir (DRV) and etravirine (ETR) for pediatric populations in sub-Saharan Africa is through the New Horizons DRV/ETR Donation Program, which was launched in 2014. Under this program, Janssen provides DRV and/or ETR free of charge to eligible national HIV/AIDS programs in sub-Saharan Africa, for use in children and adolescents up to 25 years of age.
Countries currently participating in the New Horizons Collaborative include: Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Any country that applies and is approved for receipt of donated product will become eligible for this study when they begin offering donated product to patients.
Prior to the inception of the New Horizons Collaborative, no multi-country data were collected regarding the demographic or clinical characteristics of the target patient population (i.e., children, adolescents, and young people < 25 years in need of second- or third-line HIV/AIDS treatment). Therefore, the current activity proposes to collect cross-sectional demographic and clinical data at baseline and every six months for patients receiving DRV and/or ETR across participating New Horizons countries. This activity will comprise data abstraction of key demographic, clinical, laboratory and case history indicators and outcomes on each patient who ever received DRV and/or ETR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients who ever received darunavir and/or etravirine before turning age 25 and residing in the following countries: Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, Zimbabwe.
Key inclusion criteria (3 listed)
- Ever received darunavir and/or etravirine.
- Under age 25.
- Residing in any of the following countries: Cameroon, Ethiopia, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe.
Key exclusion criteria (2 listed)
- Above age 25.
- Residing in a country not participating in the New Horizons Collaborative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical profile of patients who ever received darunavir and/or etravirine
Time frame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
Clinical and laboratory profiles of patients who ever received darunavir and/or etravirine
2 secondary outcomes
Demographic profile of patients who ever received darunavir and/or etravirine
Time frame: At initiation of darunavir and/or etravirine
Dynamics in HIV drug resistance mutations
Time frame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25
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 Sep 2026.
- Background: PubMed 14999114Clavel F, Hance AJ. HIV drug resistance. N Engl J Med. 2004 Mar 4;350(10):1023-35. doi: 10.1056/NEJMra025195. No abstract available.
- Background: PubMed 18832873Petersen ML, van der Laan MJ, Napravnik S, Eron JJ, Moore RD, Deeks SG. Long-term consequences of the delay between virologic failure of highly active antiretroviral therapy and regimen modification. AIDS. 2008 Oct 18;22(16):2097-106. doi: 10.1097/QAD.0b013e32830f97e2.
- Background: PubMed 22544205Vaz P, Augusto O, Bila D, Macassa E, Vubil A, Jani IV, Pillon R, Sandstrom P, Sutherland D, Giaquinto C, Jordan MR, Bertagnolio S. Surveillance of HIV drug resistance in children receiving antiretroviral therapy: a pilot study of the World Health Organization's generic protocol in Maputo, Mozambique. Clin Infect Dis. 2012 May;54 Suppl 4(Suppl 4):S369-74. doi: 10.1093/cid/cis006.
- Background: PubMed 17901804Puthanakit T, Aurpibul L, Oberdorfer P, Akarathum N, Kanjanavanit S, Wannarit P, Sirisanthana T, Sirisanthana V. Sustained immunologic and virologic efficacy after four years of highly active antiretroviral therapy in human immunodeficiency virus infected children in Thailand. Pediatr Infect Dis J. 2007 Oct;26(10):953-6. doi: 10.1097/INF.0b013e318125720a.
- Background: PubMed 17954540Bolton-Moore C, Mubiana-Mbewe M, Cantrell RA, Chintu N, Stringer EM, Chi BH, Sinkala M, Kankasa C, Wilson CM, Wilfert CM, Mwango A, Levy J, Abrams EJ, Bulterys M, Stringer JS. Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia. JAMA. 2007 Oct 24;298(16):1888-99. doi: 10.1001/jama.298.16.1888.
- Background: PubMed 18652994Sutcliffe CG, van Dijk JH, Bolton C, Persaud D, Moss WJ. Effectiveness of antiretroviral therapy among HIV-infected children in sub-Saharan Africa. Lancet Infect Dis. 2008 Aug;8(8):477-89. doi: 10.1016/S1473-3099(08)70180-4.
- Background: PubMed 17367540Reddi A, Leeper SC, Grobler AC, Geddes R, France KH, Dorse GL, Vlok WJ, Mntambo M, Thomas M, Nixon K, Holst HL, Karim QA, Rollins NC, Coovadia HM, Giddy J. Preliminary outcomes of a paediatric highly active antiretroviral therapy cohort from KwaZulu-Natal, South Africa. BMC Pediatr. 2007 Mar 17;7:13. doi: 10.1186/1471-2431-7-13.
- Background: PubMed 17620753Katabira ET, Oelrichs RB. Scaling up antiretroviral treatment in resource-limited settings: successes and challenges. AIDS. 2007 Jul;21 Suppl 4:S5-10. doi: 10.1097/01.aids.0000279701.93932.ef. No abstract available.
- Background: PubMed 17954553Janssens B, Raleigh B, Soeung S, Akao K, Te V, Gupta J, Vun MC, Ford N, Nouhin J, Nerrienet E. Effectiveness of highly active antiretroviral therapy in HIV-positive children: evaluation at 12 months in a routine program in Cambodia. Pediatrics. 2007 Nov;120(5):e1134-40. doi: 10.1542/peds.2006-3503. Epub 2007 Oct 22.
- Background: PubMed 19812449Arasteh K, Yeni P, Pozniak A, Grinsztejn B, Jayaweera D, Roberts A, Hoy J, De Meyer S, Vangeneugden T, Tomaka F. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14(6):859-64. doi: 10.3851/IMP1301.
- Background: PubMed 21041921Katlama C, Clotet B, Mills A, Trottier B, Molina JM, Grinsztejn B, Towner W, Haubrich R, Nijs S, Vingerhoets J, Woodfall B, Witek J. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15(7):1045-52. doi: 10.3851/IMP1662.
- Background: PubMed 21172789Imaz A, Llibre JM, Mora M, Mateo G, Camacho A, Blanco JR, Curran A, Santos JR, Caballero E, Bravo I, Gaya F, Domingo P, Rivero A, Falco V, Clotet B, Ribera E. Efficacy and safety of nucleoside reverse transcriptase inhibitor-sparing salvage therapy for multidrug-resistant HIV-1 infection based on new-class and new-generation antiretrovirals. J Antimicrob Chemother. 2011 Feb;66(2):358-62. doi: 10.1093/jac/dkq432. Epub 2010 Dec 14.
- Individual participant dataSharing planned: No
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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.
Appolinaire Tiam, MBChB, MMed principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 5 sites in 5 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 3 inclusion and 2 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Cameroon, Eswatini, Kenya, Lesotho, 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.
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?
Clinical profile of patients who ever received darunavir and/or etravirine (time frame: At initiation of darunavir and/or etravirine, thereafter every six months to the end of 2021, 12 months after turning age 25). 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 NCT04194021, which also lists 14 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 Sep 2026.