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 by an opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy. Immediate ART (iART) is defined as starting antiretroviral therapy in the first 48 hours after the hospitalization. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of infectious disease specialist.

Conditions

HIV/AIDS; ANTIRETROVIRAL TREATMENT

Keywords

HIV/AIDS; ART

Outcome Measures

Primary Outcomes (1)

• Mortality

  Compare mortality rates betweeno two groups according to the timing of ART initiation: immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)

  30 days

Secondary Outcomes (15)

• Assess survival rates

  90 days since starting antiretroviral therapy (ART)

• Assess survival rates

  180 days since starting antiretroviral therapy (ART)

• Assess survival rates

  360 days since starting antiretroviral therapy (ART)

• Length of stay

  1 year

• Asses survival rates by the CD4 count

  90 days

Study Arms (2)

Group A Immediate treatment (iART)

EXPERIMENTAL

Other: time to start the ART within 48 hours of admission to hospitalization

Other: iART

Group B Conventional treatment (cART)

ACTIVE COMPARATOR

Other: time to start the ART, after the opportunistic disease has been controlled, at the discretion of infectious disease specialist.

Other: cART

Interventions

iART OTHER

After group assignment, ART will be started within the first 48 hours after admission to the hospital. ART regimen will be decided according to each subject´s the clinical characteristics

Group A Immediate treatment (iART)

cART OTHER

After group assignment, ART is started at the discretion of the attending physician. ART regimen will be decided according to each subject´s the clinical characteristics

Group B Conventional treatment (cART)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Over 18 years old
• Time from admission to study entry: less than 48 hours
• Confirmed HIV diagnosis or high probability of HIV infection based on a positive HIV rapid test
• Having an opportunistic disease
• Subjects must be naïve to ART or have failed their first or second ART regimen or must have abandoned ART for more than 3 months

You may not qualify if:

• Meningitis due to Cryptococcus spp. or for M. tuberculosis
• Pregnancy

Sponsors & Collaborators

• Gustavo Reyes-Teran: lead

Study Sites (1)

Centro de Investigacion en Enfermedades Infecciosas

México, State of Mexico, 14080, Mexico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Officials

• GUSTAVO MD REYES-TERÁN, 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: February 18, 2019
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

ME (1)