HIV InfectionsCODENCT04326504
Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil
An observational study of HIV Infections and Clinical Outcomes, run by Fundação Bahiana de Infectologia at 3 sites in Brazil.
Trial summary
Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Clinical Outcomes, Adverse Drug Event
- How many people
- 5,000 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 Feb 2021to 28 Feb 2025
- How long will I take part?
- 36 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1).
Who may be able to join
- • Signed informed consent.
- HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- Age ≥ 15 years.
- For women of child-bearing potential, willingness to use effective contraceptives.
- Starting use of DTG-based regimen, or being initiated on a non-DTG based ART between 2014 - 2016.
Who cannot join
- • Any previous use of ART (drug-naïve group only).
- Current imprisonment, or compulsory detention (involuntary incarceration). For treatment of a psychiatric or physical illness.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, 40010-160
Estela Luz, RN, MSci, 32838123, eluz5@yahoo.com.br
Carlos Brites, MD, PhD
- Recruiting
Fundação Bahiana de Infectologia
Salvador, Estado de Bahia, 40110160
Carlos Brites, MD, PhD, crbrites@gmail.com
- Recruiting
Centro de Referência e Treinamento
São Paulo, São Paulo, 04121-000
Valdez Madruga, MD, valdezmr@uol.com.br
About this study
Official title: Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study
Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and lamivudine, for first-line ART; however, there is still a need for further data on the outcomes of DTG-based regimens for people with HIV-1.
This study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (DTG)-based regimen in a large cohort of HIV - infected patients in Brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-DTG-based ART.
Read the detailed description
CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1). Enrolled patients will be followed for 36 months.
- Conditions
- HIV Infections, Clinical Outcomes, Adverse Drug Event, Effect of Drugs
- Being tested
- No intervention
- Medical subject headings
- HIV Infections, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This will be an observational study, no intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| Patients starting DTG-based regimens | ART-naïve patients, starting cART regimens based on DTG Receives: Other: No intervention | |
| Switch cohort | Patients on stable ART regimens switching to DTG (any reason) Receives: Other: No intervention | |
| Therapy failure | ART-experienced patients switching to DTG-containing regimens due to virological failure Receives: Other: No intervention | |
| Non-DTG group | Patients who started a non-DTG containing regimen Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of therapy discontinuation due to any event for patients starting ART
The key outcomes of interest include treatment discontinuation due to any event as well as specifically due to metabolic and psychiatric events, virologic outcomes (viral suppression at 12 months, failure to ART, and genotypic results of acquired resistance), clinical outcomes (including noted side effects, retention in care, death, weight changes, hyperglycemia, diabetes, lipid changes, AIDS-defining illnesses, and recorded psychiatric and CNS effects), and special outcomes / populations (pregnancy outcomes, IRIS events, changes in HRQoL, viral hepatitis flares, and tuberculosis outcomes)
Measured: 36 months
therapy discontinuation due to any event for ART-eprerienced patients starting DTG-based regimens
therapy discontinuation due to any event for ART-experienced patients
Measured: 36 months
Secondary outcomes (4)
Exploratory outcomes
These clinical outcomes include: all-cause mortality; all AIDS-defining events; all types of cancer; bacterial pneumonia; pulmonary embolism; deep vein thrombosis; new-onset diabetes mellitus (as defined by the ADA criteria);10 coronary artery disease requiring drug treatment; congestive heart failure; peripheral vascular disease; fractures; and solicited adverse events.
Measured: 36 months
Changes in quality of life for patients switching to DTG-based regimens
Physical and Mental Components Scores will be measured. HRQoL evaluation will be performed only for patients switching to DTG-based regimens, at the time switch occurs (baseline), and after 6 and 12 months of follow up.
Measured: 6 and 12 months
HIV drug resistance
This outcome will be evaluated by collecting samples of blood prior to starting DTG-based ART. These tests will not be done in real time, and results will not be given to the investigator or participant. Once virological failure is identified, the baseline sample will be used to assess transmitted drug resistance through comparison with current resistance genotypic tests. Key mutations that are associated with viral resistance will be determined using information periodically updated by the International AIDS Society.
Measured: 36 months
Markers of CVD risk
Assessments will be made of blood lipids, smoking, blood pressure, incidence of diabetes mellitus, use of medication to lower blood pressure and lipids, and the use of aspirin, to assist in the evaluation of cardiovascular risks and benefits of early treatment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Fundação Bahiana de Infectologia
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Instituto Infectologia Evandro Chagas, Rio de Janeiro, Fundação de Medicina Tropical de Manaus, Hospital de Clinicas de Porto Alegre, Centro de Referência e Tratamento, CRT, São Paulo, SP, Hospital Partenon, Porto Alegre, Universidade Municipal de São Caetano do Sul, Universidade Federal do Rio Grande do Norte, Hospital Universitário Cassiano Antônio de Moraes/HUCAM, University of Sao Paulo, Faculdade de Medicina de Botucatu, Unesp, Sociedade Campineira de Educação e Instrução - Campinas, Fundação Universidade de Caxias do Sul - FUCS/RS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326504
- Sponsor's protocol ID
- FBAI
- Acronym
- CODE
- Status last verified
- Feb 2024
- First submitted
- 26 Mar 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dutertre M, Cuzin L, Demonchy E, Pugliese P, Joly V, Valantin MA, Cotte L, Huleux T, Delobel P, Martin-Blondel G; Dat'AIDS Study Group. Initiation of Antiretroviral Therapy Containing Integrase Inhibitors Increases the Risk of IRIS Requiring Hospitalization. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):e23-e26. doi: 10.1097/QAI.0000000000001397. No abstract available.
PubMed 28418992de Boer MG, van den Berk GE, van Holten N, Oryszcyn JE, Dorama W, Moha DA, Brinkman K. Intolerance of dolutegravir-containing combination antiretroviral therapy regimens in real-life clinical practice. AIDS. 2016 Nov 28;30(18):2831-2834. doi: 10.1097/QAD.0000000000001279.
PubMed 27824625Ciccullo A, Baldin G, Cossu MV, Passerini M, Borghetti A, Capetti A, Di Giambenedetto S. Dolutegravir Plus Lamivudine as First-Line Regimen in a Multicenter Cohort of HIV-1-Infected Patients: Preliminary Data from Clinical Practice. AIDS Res Hum Retroviruses. 2020 Jan;36(1):4-5. doi: 10.1089/AID.2019.0147. Epub 2019 Sep 30. No abstract available.
PubMed 31476877Elzi L, Erb S, Furrer H, Cavassini M, Calmy A, Vernazza P, Gunthard H, Bernasconi E, Battegay M; Swiss HIV Cohort Study Group. Adverse events of raltegravir and dolutegravir. AIDS. 2017 Aug 24;31(13):1853-1858. doi: 10.1097/QAD.0000000000001590.
PubMed 28692533Hoffmann C, Welz T, Sabranski M, Kolb M, Wolf E, Stellbrink HJ, Wyen C. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med. 2017 Jan;18(1):56-63. doi: 10.1111/hiv.12468. Epub 2016 Nov 10.
PubMed 27860104Norwood J, Turner M, Bofill C, Rebeiro P, Shepherd B, Bebawy S, Hulgan T, Raffanti S, Haas DW, Sterling TR, Koethe JR. Brief Report: Weight Gain in Persons With HIV Switched From Efavirenz-Based to Integrase Strand Transfer Inhibitor-Based Regimens. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):527-531. doi: 10.1097/QAI.0000000000001525.
PubMed 28825943Taramasso L, Ricci E, Menzaghi B, Orofino G, Passerini S, Madeddu G, Martinelli CV, De Socio GV, Squillace N, Rusconi S, Bonfanti P, Di Biagio A; CISAI Study Group. Weight Gain: A Possible Side Effect of All Antiretrovirals. Open Forum Infect Dis. 2017 Nov 3;4(4):ofx239. doi: 10.1093/ofid/ofx239. eCollection 2017 Fall.
PubMed 29255735Zash R, Makhema J, Shapiro RL. Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception. N Engl J Med. 2018 Sep 6;379(10):979-981. doi: 10.1056/NEJMc1807653. Epub 2018 Jul 24. No abstract available.
PubMed 30037297American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
PubMed 30559228Cruz LN, Fleck MP, Oliveira MR, Camey SA, Hoffmann JF, Bagattini AM, Polanczyk CA. Health-related quality of life in Brazil: normative data for the SF-36 in a general population sample in the south of the country. Cien Saude Colet. 2013 Jul;18(7):1911-21. doi: 10.1590/s1413-81232013000700006.
PubMed 23827895Laguardia J, Campos MR, Travassos C, Najar AL, Anjos LA, Vasconcellos MM. Brazilian normative data for the Short Form 36 questionnaire, version 2. Rev Bras Epidemiol. 2013 Dec;16(4):889-97. doi: 10.1590/s1415-790x2013000400009. English, Portuguese.
PubMed 24896594
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study
- ClinicalTrials.gov ID
- NCT04326504
- Acronym / sponsor ID
- CODE / FBAI
- Conditions
- HIV Infections, Clinical Outcomes, Adverse Drug Event, Effect of Drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fundação Bahiana de InfectologiaUniversity, hospital or other
- Collaborators
- University of New Mexico, Instituto Infectologia Evandro Chagas, Rio de Janeiro, Fundação de Medicina Tropical de Manaus, Hospital de Clinicas de Porto Alegre, Centro de Referência e Tratamento, CRT, São Paulo, SP, Hospital Partenon, Porto Alegre, Universidade Municipal de São Caetano do Sul, Universidade Federal do Rio Grande do Norte, Hospital Universitário Cassiano Antônio de Moraes/HUCAM, University of Sao Paulo, Faculdade de Medicina de Botucatu, Unesp, Sociedade Campineira de Educação e Instrução - Campinas, Fundação Universidade de Caxias do Sul - FUCS/RS
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 30 Mar 2020 (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.
Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and lamivudine, for first-line ART; however, there is still a need for further data on the outcomes of DTG-based regimens for people with HIV-1.
This study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (DTG)-based regimen in a large cohort of HIV - infected patients in Brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-DTG-based ART.
Detailed description
CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1). Enrolled patients will be followed for 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients starting DTG-based regimens | – | Other: No interventionART-naïve patients, starting cART regimens based on DTG |
| Switch cohort | – | Other: No interventionPatients on stable ART regimens switching to DTG (any reason) |
| Therapy failure | – | Other: No interventionART-experienced patients switching to DTG-containing regimens due to virological failure |
| Non-DTG group | – | Other: No interventionPatients who started a non-DTG containing regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1).
Key inclusion criteria (5 listed)
- • Signed informed consent.
Key exclusion criteria (2 listed)
- • Any previous use of ART (drug-naïve group only).
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 |
|---|---|---|
| No interventionThis will be an observational study, no intervention will be performed | Other | Non-DTG group, Patients starting DTG-based regimens, Switch cohort, Therapy failure |
Primary outcome
frequency of therapy discontinuation due to any event for patients starting ART
Time frame: 36 months
The key outcomes of interest include treatment discontinuation due to any event as well as specifically due to metabolic and psychiatric events, virologic outcomes (viral suppression at 12 months, failure to ART, and genotypic results of acquired resistance), clinical outcomes (including noted side effects, retention in care, death, weight changes, hyperglycemia, diabetes, lipid changes, AIDS-defining illnesses, and recorded psychiatric and CNS effects), and special outcomes / populations (pregnancy outcomes, IRIS events, changes in HRQoL, viral hepatitis flares, and tuberculosis outcomes)
therapy discontinuation due to any event for ART-eprerienced patients starting DTG-based regimens
Time frame: 36 months
therapy discontinuation due to any event for ART-experienced patients
4 secondary outcomes
Exploratory outcomes
Time frame: 36 months
Changes in quality of life for patients switching to DTG-based regimens
Time frame: 6 and 12 months
HIV drug resistance
Time frame: 36 months
Markers of CVD risk
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 28418992Dutertre M, Cuzin L, Demonchy E, Pugliese P, Joly V, Valantin MA, Cotte L, Huleux T, Delobel P, Martin-Blondel G; Dat'AIDS Study Group. Initiation of Antiretroviral Therapy Containing Integrase Inhibitors Increases the Risk of IRIS Requiring Hospitalization. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):e23-e26. doi: 10.1097/QAI.0000000000001397. No abstract available.
- Results publication: PubMed 27824625de Boer MG, van den Berk GE, van Holten N, Oryszcyn JE, Dorama W, Moha DA, Brinkman K. Intolerance of dolutegravir-containing combination antiretroviral therapy regimens in real-life clinical practice. AIDS. 2016 Nov 28;30(18):2831-2834. doi: 10.1097/QAD.0000000000001279.
- Results publication: PubMed 31476877Ciccullo A, Baldin G, Cossu MV, Passerini M, Borghetti A, Capetti A, Di Giambenedetto S. Dolutegravir Plus Lamivudine as First-Line Regimen in a Multicenter Cohort of HIV-1-Infected Patients: Preliminary Data from Clinical Practice. AIDS Res Hum Retroviruses. 2020 Jan;36(1):4-5. doi: 10.1089/AID.2019.0147. Epub 2019 Sep 30. No abstract available.
- Results publication: PubMed 28692533Elzi L, Erb S, Furrer H, Cavassini M, Calmy A, Vernazza P, Gunthard H, Bernasconi E, Battegay M; Swiss HIV Cohort Study Group. Adverse events of raltegravir and dolutegravir. AIDS. 2017 Aug 24;31(13):1853-1858. doi: 10.1097/QAD.0000000000001590.
- Results publication: PubMed 27860104Hoffmann C, Welz T, Sabranski M, Kolb M, Wolf E, Stellbrink HJ, Wyen C. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med. 2017 Jan;18(1):56-63. doi: 10.1111/hiv.12468. Epub 2016 Nov 10.
- Results publication: PubMed 28825943Norwood J, Turner M, Bofill C, Rebeiro P, Shepherd B, Bebawy S, Hulgan T, Raffanti S, Haas DW, Sterling TR, Koethe JR. Brief Report: Weight Gain in Persons With HIV Switched From Efavirenz-Based to Integrase Strand Transfer Inhibitor-Based Regimens. J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):527-531. doi: 10.1097/QAI.0000000000001525.
- Results publication: PubMed 29255735Taramasso L, Ricci E, Menzaghi B, Orofino G, Passerini S, Madeddu G, Martinelli CV, De Socio GV, Squillace N, Rusconi S, Bonfanti P, Di Biagio A; CISAI Study Group. Weight Gain: A Possible Side Effect of All Antiretrovirals. Open Forum Infect Dis. 2017 Nov 3;4(4):ofx239. doi: 10.1093/ofid/ofx239. eCollection 2017 Fall.
- Results publication: PubMed 30037297Zash R, Makhema J, Shapiro RL. Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception. N Engl J Med. 2018 Sep 6;379(10):979-981. doi: 10.1056/NEJMc1807653. Epub 2018 Jul 24. No abstract available.
- Results publication: PubMed 30559228American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
- Results publication: PubMed 23827895Cruz LN, Fleck MP, Oliveira MR, Camey SA, Hoffmann JF, Bagattini AM, Polanczyk CA. Health-related quality of life in Brazil: normative data for the SF-36 in a general population sample in the south of the country. Cien Saude Colet. 2013 Jul;18(7):1911-21. doi: 10.1590/s1413-81232013000700006.
- Results publication: PubMed 24896594Laguardia J, Campos MR, Travassos C, Najar AL, Anjos LA, Vasconcellos MM. Brazilian normative data for the Short Form 36 questionnaire, version 2. Rev Bras Epidemiol. 2013 Dec;16(4):889-97. doi: 10.1590/s1415-790x2013000400009. English, Portuguese.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Clinical Outcomes, run by Fundação Bahiana de Infectologia at 3 sites in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Brites, MD, PhD (557132838123, crbrites@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of therapy discontinuation due to any event for patients starting ART (time frame: 36 months). 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 NCT04326504, which also lists 11 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 26 Feb 2024.