Immediate ART in Subjects With Opportunistic Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Immediate treatment (iART) Other: time to start the ART within 48 hours of admission to hospitalization |
Other: iART
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
|
| Active Comparator: Group B Conventional treatment (cART) Other: time to start the ART, after the opportunistic disease has been controlled, at the discretion of infectious disease specialist. |
Other: cART
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
|
Outcome Measures
Primary Outcome Measures
- 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
- Assess survival rates [90 days since starting antiretroviral therapy (ART)]
Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)
- Assess survival rates [180 days since starting antiretroviral therapy (ART)]
Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)
- 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
- Asses survival rates by the CD4 count [90 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
- Asses survival rates by the CD4 count [180 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
- 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
- Viral load [90 days]
Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups
- Viral load [180 days]
Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups
- Viral load [360 days]
Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups
- CD4 T cell counts [90 days]
Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups
- CD4 T cell counts [180 days]
Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups
- CD4 T cell counts [360 days]
Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups
- IRIS [48 weeks]
Determine the incidence and severity of IRIS. Severity will be classified as mild or life threatening
- Adverse reactions [48 weeks]
Describe ART-related adverse events, and drug interactions
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro de Investigacion en Enfermedades Infecciosas | Mexico | Mexico | 14080 |
Sponsors and Collaborators
- Gustavo Reyes-Teran
Investigators
- Principal Investigator: GUSTAVO MD REYES-TERÁN, M.D., Instituto Nacional de Enfermedades Respiratorias
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C09-18