Clinical trial NCT03825523: Immediate ART in Subjects with Opportunistic Diseases
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
ANTIRETROVIRAL TREATMENT
Keywords: HIV/AIDS
ART
Lead sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-01-31
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Assess survival rates
timeFrame: 90 days since starting antiretroviral therapy (ART)
measure: Assess survival rates
timeFrame: 180 days since starting antiretroviral therapy (ART)
measure: Assess survival rates
timeFrame: 360 days since starting antiretroviral therapy (ART)
measure: Length of stay
timeFrame: 1 year
measure: Asses survival rates by the CD4 count
timeFrame: 90 days
measure: Asses survival rates by the CD4 count
timeFrame: 180 days
measure: Asses survival rates by the CD4 count
timeFrame: 360 days
measure: Viral load
timeFrame: 90 days
measure: Viral load
timeFrame: 180 days
measure: Viral load
timeFrame: 360 days
measure: CD4 T cell counts
timeFrame: 90 days
measure: CD4 T cell counts
timeFrame: 180 days
measure: CD4 T cell counts
timeFrame: 360 days
measure: IRIS
timeFrame: 48 weeks
measure: Adverse reactions
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Centro de Investigacion en Enfermedades Infecciosas
Study officials:
affiliation: Instituto Nacional de Enfermedades Respiratorias
name: GUSTAVO MD REYES-TERÁN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: