Immediate ART in Subjects with Opportunistic Diseases
- Conditions
- ANTIRETROVIRAL TREATMENTHIV/AIDS
- Interventions
- Other: cARTOther: iART
- Registration Number
- NCT03825523
- Lead Sponsor
- Gustavo Reyes-Teran
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- 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
- Meningitis due to Cryptococcus spp. or for M. tuberculosis
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Conventional treatment (cART) cART Other: time to start the ART, after the opportunistic disease has been controlled, at the discretion of infectious disease specialist. Group A Immediate treatment (iART) iART Other: time to start the ART within 48 hours of admission to hospitalization
- Primary Outcome Measures
Name Time Method Mortality 30 days Compare mortality rates betweeno two groups according to the timing of ART initiation: immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)
- Secondary Outcome Measures
Name Time Method Viral load 360 days Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups
Asses survival rates by the CD4 count 360 days Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART) stratified by CD4+ T cell count at study entry
CD4 T cell counts 360 days Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups
Assess survival rates 360 days since starting antiretroviral therapy (ART) Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)
Length of stay 1 year Compare length of hospitalization between both groups
Adverse reactions 48 weeks Describe ART-related adverse events, and drug interactions
IRIS 48 weeks Determine the incidence and severity of IRIS. Severity will be classified as mild or life threatening
Trial Locations
- Locations (1)
Centro de Investigacion en Enfermedades Infecciosas
🇲🇽Mexico, Mexico