Immediate ART in Subjects With Opportunistic Diseases

NCT03825523 | Completed DMC

• 1 other identifier: C09-18
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of the infectious disease specialist.

Conditions

HIV/AIDS; ANTIRETROVIRAL TREATMENT

Keywords

HIV/AIDS; ART

Outcome Measures

Primary Outcomes (1)

• Mortality at 30 days.

  Compare all cause mortality within 30 days of antiretroviral therapy (ART) initiation between immediate ART (iART) versus conventional ART (cART).

  30 days from ART initiation

Secondary Outcomes (6)

• Mortality at 90, 180 and 365 days.

  90, 180, 360 days from ART initiation.

• Length of hospital stay.

  From hospital admission to discharge (assessed up to 365 days).

• Time to opportunistic infection resolution or recurrence.

  Up to 365 days from ART initiation.

• Incidence and classification of Immune Reconstitution Inflammatory Syndrome (IRIS).

  Up to 365 days from ART initiation.

• Incidence of adverse events Grade 2, 3, and 4.

  Up to 365 days from ART initiation.

Study Arms (2)

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.

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.

Drug: Antiretroviral Therapy (ART)

Interventions

Antiretroviral Therapy (ART) DRUG

Immediate initiation of ART within 48 hours of hospital admission.

Immediate Antiretroviral Therapy (iART).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustavo Reyes-Teran: lead

Study Sites (1)

Centro de Investigacion en Enfermedades Infecciosas

México, State of Mexico, 14080, Mexico

Location

Related Publications (6)

• 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.

  PMID: 20617176 BACKGROUND

• Koenig 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.

  PMID: 28742880 BACKGROUND

• Havlir 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.

  PMID: 22010914 BACKGROUND

• Zolopa 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.

  PMID: 19440326 BACKGROUND

• Blanc 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.

  PMID: 22010913 BACKGROUND

• Abdool 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.

  PMID: 20181971 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Amy B. Peralta-Prado, M.D.

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 31, 2019
• Study Start: January 29, 2018
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

ME (1)