HIV Infection
Conditions
Keywords
critically ill patients, HIV infection, HAART, mortality
Brief summary
The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.
Interventions
DRUGearly HAART
Initiation of HAART within 5 days of ICU admission
DRUGLate HAART
Initiation of HAART after ICU discharge
Sponsors
Hospital Nossa Senhora da Conceicao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infection * CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with HBV or HCV, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness
Exclusion criteria
* Regular use of HAART * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | 4 weeks | It is a estimative of length of hospital stay |
Secondary
| Measure | Time frame |
|---|---|
| 6-month mortality | 6 months |
Countries
Brazil
Outcome results
None listed