HIV/AIDSTARiNCT03825523
Immediate ART in Subjects With Opportunistic Diseases
A study testing Antiretroviral Therapy (ART) in people with HIV/AIDS and ANTIRETROVIRAL TREATMENT, run by Gustavo Reyes-Teran at 1 site in Mexico.
Trial summary
The aim of this study is to compare the clinical response and mortality rate due to opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy (ART). Immediate ART (iART) is defined as starting antiretroviral therapy within the first 48 hours after hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, ANTIRETROVIRAL TREATMENT
- What is being tested?
- Antiretroviral Therapy (ART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMexico
- Study dates
- 29 Jan 2018to 5 Aug 2025
- Phase
- Interventional
- 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
- HIV infection documented by ELISA or rapid test.
- Age 18 years or older.
- Hospitalized at the emergency department, intensive care unit, or clinical pulmonology ward of the National Institute of Respiratory Diseases (INER) with clinical criteria of an opportunistic infection or AIDS-related malignancy.
- Candidate to initiate first ART regimen or presenting with first- or second-line ART failure.
- ART-naïve or with ART discontinuation for at least 3 months prior to enrollment.
Who cannot join
- Diagnosis or clinical symptoms suggestive of cryptococcal meningitis, tuberculous meningitis, or meningitis of any other cause.
- Pregnant women.
- Admitted exclusively for treatment of neurosyphilis without any other active opportunistic infection.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, 14080
About this study
Official title: Impact of the Timing of Antiretroviral Therapy Initiation (Immediate Versus Early) on the Mortality Rate of HIV/AIDS Patients Hospitalized With an Opportunistic Disease
The aim of this study is to compare the clinical response and mortality rate due to opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy (ART).
Immediate ART (iART) is defined as starting antiretroviral therapy within the first 48 hours after hospitalization. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of the infectious disease specialist.
Read the detailed description
This is an open-label, randomized clinical trial conducted at the Center for Research in Infectious Diseases (CIENI) of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" (INER) in Mexico City. Adults (≥18 years) with confirmed HIV diagnosis and active opportunistic infections or AIDS-related malignancies are eligible. Participants must be ART-naïve or have discontinued ART for at least 3 months. Key exclusions include suspected cryptococcal meningitis, tuberculous meningitis, or cytomegalovirus retinitis.
Sample Size Calculation Sample size was calculated using a difference in proportions formula with 95% confidence level, 90% power, and 5% expected difference between groups. Based on 2022 hospitalization data (145 patients with HIV hospitalized) and a 6.9% mortality rate, assuming a 5% absolute reduction in mortality (from 6.9% to 1.9%) in the experimental group, the initial required sample size was 359 participants. This was adjusted for finite population (n=145), yielding 103 participants. Accounting for an anticipated 10% loss to follow-up, the final sample size was set at 114 participants (57 per group).
Study Procedures
Participants are stratified by CD4+ T-cell count (<50 vs. ≥50 cells/μL) and randomized 1:1 to either:
- Immediate ART (iART): Initiation of ART within 48 hours of hospital admission
- Conventional ART (cART): Initiation of ART once the opportunistic infection is controlled, at the discretion of the treating physician.
Follow-up and Assessments
Participants are followed for 48 weeks with visits at days 7, 14, 30, 90, 180, and 365. At each visit, the following are measured:
- HIV-1 RNA viral load.
- CD4+ and CD8+ T-cell counts.
- Inflammatory markers (C-reactive protein, D-dimer).
- Clinical outcomes (opportunistic infection resolution/recurrence, IRIS, adverse events, mortality).
Primary Outcome All-cause mortality at 30 days from ART initiation.
Secondary Outcomes
- Mortality at 90, 180, and 360 days.
- Length of hospital stay.
- Time to opportunistic infection resolution or recurrence.
- Incidence and severity of Immune Reconstitution Inflammatory Syndrome (IRIS).
- Incidence of adverse events Grade 2, 3, and 4.
- Kinetics of HIV viremia and CD4+ T-cell count
Interim Analysis A planned preliminary analysis will be conducted once 50% of the sample size completed 90 days of follow-up, to assess the safety and efficacy of immediate ART initiation .
Ethics and Registration The study was approved by the INER Research and Ethics Committee (Approval Number C09-18). All participants provided written informed consent.
- Conditions
- HIV/AIDS, ANTIRETROVIRAL TREATMENT
- Being tested
- Antiretroviral Therapy (ART)
- Keywords
- HIV/AIDS, ART
- 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.
Antiretroviral Therapy (ART)Drug
Immediate initiation of ART within 48 hours of hospital admission.
Antiretroviral Therapy (ART)Drug
Deferred initiation of ART, with timing determined by the treating physician based on clinical stability and control of the opportunistic infection.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Antiretroviral Therapy (iART). | Experimental | Participants randomized to this arm will initiate antiretroviral therapy (ART) within 48 hours of hospital admission. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation integrase strand transfer inhibitor (INSTI)-based regimens (e.g., bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]), unless contraindicated. Receives: Drug: Antiretroviral Therapy (ART) |
| Conventional Antiretroviral Therapy (cART). | Active comparator | Participants randomized to this arm will initiate ART once the opportunistic infection is considered controlled by the treating physician, at their discretion. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation INSTI-based regimens (e.g., BIC/FTC/TAF), unless contraindicated. Receives: Drug: Antiretroviral Therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days.
Compare all cause mortality within 30 days of antiretroviral therapy (ART) initiation between immediate ART (iART) versus conventional ART (cART).
Measured: 30 days from ART initiation
Secondary outcomes (6)
Mortality at 90, 180 and 365 days.
Compare all cause mortality at 90, 180 and 365 days of follow-up, assessed from the date of antiretroviral therapy (ART) initiation between immediate ART (iART) versus conventional ART (cART).
Measured: 90, 180, 360 days from ART initiation.
Length of hospital stay.
Total number of days from hospital admission to hospital discharge.
Measured: From hospital admission to discharge (assessed up to 365 days).
Time to opportunistic infection resolution or recurrence.
Time from ART initiation to clinical resolution of the opportunistic infection or evidence of recurrence, as documented by clinical, radiological, or microbiological criteria.
Measured: Up to 365 days from ART initiation.
Incidence and classification of Immune Reconstitution Inflammatory Syndrome (IRIS).
Incidence of IRIS, classified as severe (life-threatening) or non-severe.
Measured: Up to 365 days from ART initiation.
Incidence of adverse events Grade 2, 3, and 4.
Incidence of treatment-related adverse events graded as Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life-threatening).
Measured: Up to 365 days from ART initiation.
Kinetics of HIV viremia and CD4+ T-cell count.
Longitudinal changes in HIV-1 RNA viral load (log10 copies/mL) and absolute CD4+ T-cell count (cells/μL) over time.
Measured: Baseline, days 7, 14, 30, 90, 180 and 365.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start29 Jan 2018
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified randomization will be generated by an electronic system, in blocks of 6 and 8, and a 1:1 ratio, according to the CD4+ T cell count. Group A: Immediate treatment (iART). Start ART within 48 hours of admission and hospitalization; Group B: Conventional treatment (cART). Start the ART once the opportunistic infection is under control at the discretion of infectious disease specialist.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustavo Reyes-Teran
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Investigators
- Amy B. Peralta-Prado, M.D., Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825523
- Sponsor's protocol ID
- C09-18
- Acronym
- TARi
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2019
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grant PM, Komarow L, Andersen J, Sereti I, Pahwa S, Lederman MM, Eron J, Sanne I, Powderly W, Hogg E, Suckow C, Zolopa A. Risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred ART during an opportunistic infection. PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.
PubMed 20617176Koenig SP, Dorvil N, Devieux JG, Hedt-Gauthier BL, Riviere C, Faustin M, Lavoile K, Perodin C, Apollon A, Duverger L, McNairy ML, Hennessey KA, Souroutzidis A, Cremieux PY, Severe P, Pape JW. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017 Jul 25;14(7):e1002357. doi: 10.1371/journal.pmed.1002357. eCollection 2017 Jul.
PubMed 28742880Havlir DV, Kendall MA, Ive P, Kumwenda J, Swindells S, Qasba SS, Luetkemeyer AF, Hogg E, Rooney JF, Wu X, Hosseinipour MC, Lalloo U, Veloso VG, Some FF, Kumarasamy N, Padayatchi N, Santos BR, Reid S, Hakim J, Mohapi L, Mugyenyi P, Sanchez J, Lama JR, Pape JW, Sanchez A, Asmelash A, Moko E, Sawe F, Andersen J, Sanne I; AIDS Clinical Trials Group Study A5221. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1482-91. doi: 10.1056/NEJMoa1013607.
PubMed 22010914Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.
PubMed 19440326Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.
PubMed 22010913Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
PubMed 20181971
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Timing of Antiretroviral Therapy Initiation (Immediate Versus Early) on the Mortality Rate of HIV/AIDS Patients Hospitalized With an Opportunistic Disease
- ClinicalTrials.gov ID
- NCT03825523
- Acronym / sponsor ID
- TARi / C09-18
- Conditions
- HIV/AIDS, ANTIRETROVIRAL TREATMENT
- Keywords
- HIV/AIDS, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Gustavo Reyes-TeranOther government
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 31 Jan 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 aim of this study is to compare the clinical response and mortality rate due to opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy (ART).
Immediate ART (iART) is defined as starting antiretroviral therapy within the first 48 hours after hospitalization. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of the infectious disease specialist.
Detailed description
This is an open-label, randomized clinical trial conducted at the Center for Research in Infectious Diseases (CIENI) of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" (INER) in Mexico City. Adults (≥18 years) with confirmed HIV diagnosis and active opportunistic infections or AIDS-related malignancies are eligible. Participants must be ART-naïve or have discontinued ART for at least 3 months. Key exclusions include suspected cryptococcal meningitis, tuberculous meningitis, or cytomegalovirus retinitis.
Sample Size Calculation Sample size was calculated using a difference in proportions formula with 95% confidence level, 90% power, and 5% expected difference between groups. Based on 2022 hospitalization data (145 patients with HIV hospitalized) and a 6.9% mortality rate, assuming a 5% absolute reduction in mortality (from 6.9% to 1.9%) in the experimental group, the initial required sample size was 359 participants. This was adjusted for finite population (n=145), yielding 103 participants. Accounting for an anticipated 10% loss to follow-up, the final sample size was set at 114 participants (57 per group).
Study Procedures
Participants are stratified by CD4+ T-cell count (<50 vs. ≥50 cells/μL) and randomized 1:1 to either:
- Immediate ART (iART): Initiation of ART within 48 hours of hospital admission
- Conventional ART (cART): Initiation of ART once the opportunistic infection is controlled, at the discretion of the treating physician.
Follow-up and Assessments
Participants are followed for 48 weeks with visits at days 7, 14, 30, 90, 180, and 365. At each visit, the following are measured:
- HIV-1 RNA viral load.
- CD4+ and CD8+ T-cell counts.
- Inflammatory markers (C-reactive protein, D-dimer).
- Clinical outcomes (opportunistic infection resolution/recurrence, IRIS, adverse events, mortality).
Primary Outcome All-cause mortality at 30 days from ART initiation.
Secondary Outcomes
- Mortality at 90, 180, and 360 days.
- Length of hospital stay.
- Time to opportunistic infection resolution or recurrence.
- Incidence and severity of Immune Reconstitution Inflammatory Syndrome (IRIS).
- Incidence of adverse events Grade 2, 3, and 4.
- Kinetics of HIV viremia and CD4+ T-cell count
Interim Analysis A planned preliminary analysis will be conducted once 50% of the sample size completed 90 days of follow-up, to assess the safety and efficacy of immediate ART initiation .
Ethics and Registration The study was approved by the INER Research and Ethics Committee (Approval Number C09-18). All participants provided written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratified randomization will be generated by an electronic system, in blocks of 6 and 8, and a 1:1 ratio, according to the CD4+ T cell count. Group A: Immediate treatment (iART). Start ART within 48 hours of admission and hospitalization; Group B: Conventional treatment (cART). Start the ART once the opportunistic infection is under control at the discretion of infectious disease specialist.
| Arm | Type | Receives |
|---|---|---|
| Immediate Antiretroviral Therapy (iART). | Experimental | Drug: Antiretroviral Therapy (ART)Participants randomized to this arm will initiate antiretroviral therapy (ART) within 48 hours of hospital admission. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation integrase strand transfer inhibitor (INSTI)-based regimens (e.g., bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]), unless contraindicated. |
| Conventional Antiretroviral Therapy (cART). | Active comparator | Drug: Antiretroviral Therapy (ART)Participants randomized to this arm will initiate ART once the opportunistic infection is considered controlled by the treating physician, at their discretion. The regimen will be selected by the treating physician based on clinical guidelines, with preference for second-generation INSTI-based regimens (e.g., BIC/FTC/TAF), unless contraindicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection documented by ELISA or rapid test.
- Age 18 years or older.
- Hospitalized at the emergency department, intensive care unit, or clinical pulmonology ward of the National Institute of Respiratory Diseases (INER) with clinical criteria of an opportunistic infection or AIDS-related malignancy.
- Candidate to initiate first ART regimen or presenting with first- or second-line ART failure.
- ART-naïve or with ART discontinuation for at least 3 months prior to enrollment.
Key exclusion criteria (3 listed)
- Diagnosis or clinical symptoms suggestive of cryptococcal meningitis, tuberculous meningitis, or meningitis of any other cause.
- Pregnant women.
- Admitted exclusively for treatment of neurosyphilis without any other active opportunistic infection.
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 |
|---|---|---|
| Antiretroviral Therapy (ART)Immediate initiation of ART within 48 hours of hospital admission. | Drug | Immediate Antiretroviral Therapy (iART). |
| Antiretroviral Therapy (ART)Deferred initiation of ART, with timing determined by the treating physician based on clinical stability and control of the opportunistic infection. | Drug | Conventional Antiretroviral Therapy (cART). |
Primary outcome
Mortality at 30 days.
Time frame: 30 days from ART initiation
Compare all cause mortality within 30 days of antiretroviral therapy (ART) initiation between immediate ART (iART) versus conventional ART (cART).
6 secondary outcomes
Mortality at 90, 180 and 365 days.
Time frame: 90, 180, 360 days from ART initiation.
Length of hospital stay.
Time frame: From hospital admission to discharge (assessed up to 365 days).
Time to opportunistic infection resolution or recurrence.
Time frame: Up to 365 days from ART initiation.
Incidence and classification of Immune Reconstitution Inflammatory Syndrome (IRIS).
Time frame: Up to 365 days from ART initiation.
Incidence of adverse events Grade 2, 3, and 4.
Time frame: Up to 365 days from ART initiation.
Kinetics of HIV viremia and CD4+ T-cell count.
Time frame: Baseline, days 7, 14, 30, 90, 180 and 365.
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 30 Jun 2026.
- Background: PubMed 20617176Grant PM, Komarow L, Andersen J, Sereti I, Pahwa S, Lederman MM, Eron J, Sanne I, Powderly W, Hogg E, Suckow C, Zolopa A. Risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred ART during an opportunistic infection. PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.
- Background: PubMed 28742880Koenig SP, Dorvil N, Devieux JG, Hedt-Gauthier BL, Riviere C, Faustin M, Lavoile K, Perodin C, Apollon A, Duverger L, McNairy ML, Hennessey KA, Souroutzidis A, Cremieux PY, Severe P, Pape JW. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017 Jul 25;14(7):e1002357. doi: 10.1371/journal.pmed.1002357. eCollection 2017 Jul.
- Background: PubMed 22010914Havlir DV, Kendall MA, Ive P, Kumwenda J, Swindells S, Qasba SS, Luetkemeyer AF, Hogg E, Rooney JF, Wu X, Hosseinipour MC, Lalloo U, Veloso VG, Some FF, Kumarasamy N, Padayatchi N, Santos BR, Reid S, Hakim J, Mohapi L, Mugyenyi P, Sanchez J, Lama JR, Pape JW, Sanchez A, Asmelash A, Moko E, Sawe F, Andersen J, Sanne I; AIDS Clinical Trials Group Study A5221. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1482-91. doi: 10.1056/NEJMoa1013607.
- Background: PubMed 19440326Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.
- Background: PubMed 22010913Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.
- Background: PubMed 20181971Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Amy B. Peralta-Prado, M.D. principal investigator
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiretroviral Therapy (ART) in people with HIV/AIDS and ANTIRETROVIRAL TREATMENT, run by Gustavo Reyes-Teran at 1 site in Mexico.
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 3 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Mortality at 30 days. (time frame: 30 days from ART initiation). 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 NCT03825523, which also lists 6 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 30 Jun 2026.