Early Antiviral Therapy for Critically Ill HIV Infected Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: HAART |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Hospital mortality [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]It is a estimative of length of hospital stay
- 6-month mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 344 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Early antiviral therapy |
Drug: HAART
Initiation of HAART within 5 days of ICU admission
|
| Active Comparator: Conventional therapy |
Drug: HAART
Initiation of HAART after ICU discharge
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Marcio M Boniatti, PhD | 33572221 | marciobt@terra.com.br |
| Brazil | |
| Hospital Nossa Senhora da Conceicao | Recruiting |
| Porto Alegre, Rio Grande do Sul, Brazil | |
| Contact: Marcio M Boniatti, PhD 33572221 marciobt@terra.com.br | |
| Principal Investigator: Marcio M Boniatti, PhD | |
More Information
No publications provided
| Responsible Party: | Marcio Manozzo Boniatti, Principal investigator, Hospital Nossa Senhora da Conceicao |
| ClinicalTrials.gov Identifier: | NCT01455688 History of Changes |
| Other Study ID Numbers: | ARV-0112 |
| Study First Received: | October 17, 2011 |
| Last Updated: | May 1, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital Nossa Senhora da Conceicao:
|
critically ill patients HIV infection HAART mortality |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Critical Illness Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Disease Attributes Pathologic Processes Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013