Immediate ART in Subjects with Opportunistic Diseases (TARi)

Gustavo Reyes-Teran

Status: Active, not recruiting

Conditions: ANTIRETROVIRAL TREATMENT; HIV/AIDS

Treatments: Other: cART; Other: iART

Study type: Interventional

Funder types: Other

Identifiers

NCT03825523

C09-18

Details and patient eligibility

About

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.

Full description

Sample size was calculated using formula, of difference in proportions formula using a beta of 0.1, alpha of 0.05 and an expected difference in mortality of 20%, The sample size is 225 subjects in each group. Informed consent will be obtained. Patients will be allocated to each group (iART or cART) after randomization stratified by the CD4+ T cell count (less or more than 50 cells/mm3).

Plasma viral load and CD4+ T cell count will be measured at study entry and at weeks 2, 4, 12, 24 and 48 after ART initiation. Clinical outcomes will be: mortality at 4, 12, 24, and 48 weeks, length of hospitalization (measured in days), clinical and microbiological cure of the opportunistic disease, incidence and severity of immune reconstitution of inflammatory syndrome (IRIS), and adverse drug reactions and interactions.

Once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy of iART; if differences in the mortality are observed, the study will be terminated.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Group A Immediate treatment (iART)

Experimental group

Description:

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

Treatment:

Other: iART

Group B Conventional treatment (cART)

Active Comparator group

Description:

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

Treatment:

Other: cART